Pharma Bio World, March 2014 by Pharma Bio World

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6 ď&#x201A;&#x192; March 2014

Contents.indd 6

Pharma Bio World

19-03-2014 11:17:31

EXPERT’S TAKE 10

Designing and Successful Exceution of a Compliance Programme – Lene Sinkbæk Bjerregaard & Prabhakar Shirse, NNE Pharmaplan

INTERVIEW 20 20

“Innovation has been the mainstay of the company.” – Dr Villoo Morawala Patell, CMD, Avesthagen

FEATURES 24

Pulsatile Drug Delivery: A Leading Advent to Chronopharmacotherapy – Dr. N.Kanaka Durga Devi & B.Sai Mrudula, K.V.S.R Siddhartha College of Pharmaceutical Sciences

The Development of Single-Use Aseptic Processing Systems – John Boehm, Colder Products Company

Expanding Your Business Development Strategy with Smart Competitive Intelligence – Tim Miller, Thomson Reuters Life Sciences

Moving From Batch to Continuous: Striving For Greater Efficiency in Pharmaceutical Manufacture - Yogin Chandorkar, Freeman Technology

Aimil Limited & Jamie Clayton,

MARKET RESEARCH 38

Need for Innovation in the Global Pharma Industry – Dr E Saneesh, Frost & Sullivan

NEWS FEATURES 40

Is India Ready for Bio Warfare? – Mahesh Kallayil

NEWS UPDATE 42

Pharma News

Press Releases

Biotech News

CORPORATE AFFAIRS 55

Product Trends

Events Diary

BACKYARD 40

Bookshelf

AD Index

Cover page image courtesy: Michigan Center for Biologic Nanotechnology

8  March 2014

Contents.indd 8

Next Issue Focus: Clinical Trials

Pharma Bio World

20-03-2014 10:32:04

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expert's take

Designing and Successful Exceution of a Compliance Programme Lene Sinkbæk Bjerregaard Senior Technology Partner, GMP & Compliance Global Business Development NNE Pharmaplan

Prabhakar Shirse Head - Validation & GMP Compliance NNE Pharmaplan India Limited

A quality system is a fundamental and necessary component for any pharmaceutical manufacturer seeking regulatory approval anywhere in the world; these regulations are also known as current Good Manufacturing Practices (cGMP). The purpose of a quality system is to achieve compliance of all elements of the pharmaceutical manufacturing process that has potential to affect product quality and patient safety. This article chalks out a compliance model for pharma corporations to emulate so as to ease conformation to the regulatory norms. 10 March 2014

Designing and Successful Exceution of a Compliance Programme.indd 10

harmaceuticals and compliance have a long association; however the development of each of these has been on a different stride. At that juncture pharmaceuticals came first with a concern of safety and efficacy. In the mid of twentieth century, incidents resulted in the death of countless patients, led to the formation of GMP. Recently, a “c” has been added in front of GMP, in order to indicate the requirements for GMP that will change and improve with new technologies and methods of working to enhance the quality of pharmaceuticals. A series of improvements in the 21st century has pushed this idea to arise with 21st century initiatives of FDA, ICH Q8, Q9, Q10 & Q11 Guidelines focused on quality risk management (QRM) and Process Analytical Technology – PAT to make sure that consumers get only safe and quality pharmaceuticals. One of the latest practices being implemented is Quality by Design (QbD) approach which is more scientific and engineering based, unlike the previous regulatory practices that are empirical in nature (Quality by testing). Best – in- class compliance is an opportunity for market differentiation. ‘’If you can’t describe what you are doing as a process, you don’t know what you are doing.” - W. Edwards Deming Traditionally it has been perceived as necessary to validate a process and then

lock it and never change it. However, recently the regulatory requirements have started to change; requiring more focus on understanding the science, the process, the risks and on building quality into the manufacturing process. This has to start already in the research and development phase, and the understanding gained here must be the platform used when designing a facility for commercial manufacturing. Therefore, it is necessary to implement standards and tools built on ASTM E-2500 and Q10 throughout the life cycle of the manufacturing system. The quality system must cover the design, manufacture, packing and labelling, storage and delivery of pharmaceutical manufacturing systems. Compliance Design A risk-based and science-based approach shall be applied to the specification, design, and verification of manufacturing systems and equipment that have the potential to affect product quality, patient safety and is the systematic, efficient, and effective way of ensuring that manufacturing systems and equipment are fit for intended use; that risk to product quality and consequently to patient safety are effectively managed to the extent that these are affected by such systems and equipment.

Traditionally it has been perceived as necessary to validate a process and then lock it and never change it. However, recently the regulatory requirements have started to change; requiring more focus on understanding the science, the process, the risks and on building quality into the manufacturing process. Pharma Bio World

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expert's take design and related acceptance criteria shall be documented. Good Engineering Practice: This practice is the established engineering method and standards such as specification, design, installation and verification activities including GxP, safety, health, environmental, ergonomic, operational, maintenance, recognized industry standards and related statutory requirements that are applied throughout the life cycle to deliver appropriate and effective solutions to produce documentation covering planning, specification, design, verification, installation, acceptance and maintenance.

Figure 1: Compliance Design

The objectives are to provide manufacturing capability to support well-defined and controlled processes that can consistently produce products meeting defined quality requirements and to support continuous process capability improvements and enable innovation such as the implementation of Process Analytical Technology intended to satisfy both national and international regulatory expectations respectively in ensuring that manufacturing systems and equipment are fit for intended use. It also aims to satisfy requirements for design, installation, operation, and performance applying concepts and principles introduced in the FDA initiative: Pharmaceutical cGMPs for the 21st Centuryâ&#x20AC;&#x201D;A Risk-Based Approach as is also consistent with the framework described in ICH Q8 and ICH Q9. Proposed E55 standards to be published by ASTM International. Key concepts applied in designing the compliance program shall be: Risk- and science based approach: This approach supports the specification, design, and verification of manufacturing system at each stage based on scientific knowledge. The level of documentation of the quality 12 ď&#x201A;&#x192;March 2014

Designing and Successful Exceution of a Compliance Programme.indd 12

risk management shall commensurate with the risk to product quality and patient safety. Analyzing the process parameters risk to critical quality attributes (CQAs), and hereby identifying the critical process parameters (CPPs). This will be the basis for a process control strategy. Prior production experience shall be used as the basis for making science based decisions to ensure that the manufacturing systems are designed and verified to be fit for their intended use. Critical Aspects of Manufacturing Systems: The critical aspects such as features, abilities, and performance or characteristics necessary for the manufacturing process and systems that ensure consistent product quality and patient safety shall be identified and documented based on scientific product and process understanding. Quality by Design: This concept should be applied to ensure that critical aspects are designed into systems during the specification and design process. Assurance that manufacturing systems are fit for intended use shall be achieved by a planned and structured verification approach applied throughout the system life cycle and the critical aspects of the

Provisions related to quality shall be included in specification, design, procurement, and other contractual documents with desired degree of oversight and control achieved by suitable verification of execution, construction and installation activities. Use of Vendor Documentation: Vendor documentation including test documents shall be used as part of the verification documentation provided the regulated company has assessed the vendor, and has evidence of an acceptable vendor quality system, vendor technical capability and vendor application of GEP such that information obtained from the vendor will be accurate and suitable to meet the purpose of verification. The decision and justification to use vendor documentation to support the verification of critical aspects of the manufacturing element shall be based on the intended use of the manufacturing system and shall be documented and approved by the quality unit. Continuous Improvement: In this section opportunities for improvements shall be sought based on periodic review and evaluation, operational and performance data and root-cause analysis of failures, where change management shall be used for implementation of technical improvements. Pharma Bio World

18-03-2014 17:49:30

expert's take for operational use. Such documents shall include a review of the results and a review of any non-conformance with stated acceptance criteria of critical aspects covering a clear statement as to whether or not the manufacturing system is fit for intended use based on the review. The persons involved in making this determination shall be identified and documented.

Figure 2: Quality System

Execution of Compliance The process of compliance in manufacturing system specification, design, and verification shall be commenced by describing the requirements, acceptance and release criteria supported by quality risk management & design review as appropriate and change management applied during the process throughout the life-cycle along with quality system and essential documentation, contamination control, in-process controls, cleaning and disinfection, facility design and operation, containers & closures, environmental monitoring, quality assurance, laboratory and IT systems, employee health and safety. Definition of Requirements: At this stage specific requirements shall be identified to provide on the basis of specification, design, and verification of the manufacturing system relative to quality and safety shall be based upon product - process knowledge including sources of variability in the product and process, the identification of critical quality attributes and information of process control strategy based on scientific data gathered during experimental and development stage and related Regulatory requirements. Specification and Design: At this stage, appropriate mechanisms to communicate required inputs, including product quality to 16 ď&#x201A;&#x192;March 2014

Designing and Successful Exceution of a Compliance Programme.indd 16

those liable for design shall be developed to ensure that the manufacturing system has been designed is appropriate to product and process requirements. Verification: At this stage a defined systematic approach shall be followed to verify that manufacturing systems are fit for intended use, have been properly installed and are operating correctly with generation of detailed documentation based on risk, associated with quality and safety. The verification plan developed for systems containing critical aspects shall be approved by the quality unit. The completion of verification activity shall be documented and all documents shall be reviewed by independent qualified person and all the observed deviations shall be addressed and resolved. Acceptance Criteria: At this stage the acceptance criteria of critical aspects shall be defined that a manufacturing system must satisfy in order to be fit for intended use and to be accepted by a user and approved by the quality unit. Release Criteria: At this stage the qualified person shall confirm that the manufacturing system is fit for intended use and this confirmation shall be documented. Such documents shall be prepared and approved by the quality unit. Following these approvals the manufacturing system shall be released

Quality Risk Management: At appropriate stages of manufacturing, the risk assessment, control, communication and review of identified risks to the quality of the drug and safety of the patient should be completed. Based on risk assessments, appropriate controls and verification techniques shall be selected to manage risk to an acceptable level, centered on critical aspects of the manufacturing system. The level of control shall be appropriate with the level of risk to quality and safety. Design Review: This stage shall include planning and reviewing of specifications, design development and continuous improvement changes, evaluation of deliverables against standards and requirements, identification of problems, and proposing required corrective actions performed as appropriate throughout the life-cycle of the manufacturing system. The critical aspects of manufacturing systems must be addressed and risks to product quality and patient safety identified. Unacceptable risks can be mitigated and performed and documented by qualified persons with statements that the item in question is acceptable, provided the proposed corrective actions are completed. Change Management: This process shall be established and be applied before acceptance throughout the life-cycle and it shall be managed and approved by qualified persons. Changes affecting critical aspects of manufacturing systems shall be communicated to the quality unit. Operational change management shall be applied after acceptance and prior to manufacturing for commercial use. Under this, all changes related to specific requirements relative to product quality and patient safety will require prior approval by the quality unit. Pharma Bio World

18-03-2014 17:50:02

december ads.indd 15

20-01-2014 17:50:45

expert's take Quality System and Essential Documentation: In terms of quality system, the site master file and quality manuals shall be mandatory for compliance. Good documentation system constitutes an essential part of the compliance. Documents shall be clearly written & easily understandable beside accurate, complete, legible and timely records. Data shall be consistent with the source document. Acquisition and control of materials: Handing suppliers, their quality systems, storage and test of incoming materials is one of the key elements in ensuring good quality. Contamination Control: Control of contamination specifies warrant recourse to specialist publication. Nevertheless the causes of contamination within pharmaceutical manufacturing are of great importance. The primary causes of contamination were identified as people, environment, records, equipment, procedures, ingredients, product itself. In-Process Controls: In terms of compliance, sampling shall be undertaken to a pre-approved sampling plan and all test methods shall be validated and the data is regularly reviewed as part of batch review. An in-process test to determine the completion of a reaction or processing step that does not meet the target value is considered as OOS or deviation. The process is continued until the target is reached. Cleaning and Disinfection: Cleaning and disinfection is an important part of contamination control. It is important to build cleanable surfaces for easy to clean and disinfect. A disinfectant used shall have wide spectrum of activity. Facility Design and Operation: The design of facility shall be such that contamination is minimized Containers and Closures: Aside form the pharmaceutical use of product stability 18 ď&#x201A;&#x192;March 2014

Designing and Successful Exceution of a Compliance Programme.indd 18

the choice of the means of primary containment is a function of factors such as protection of physical composition and microbial contamination. Environmental Monitoring: The monitoring program is designed to describe the routine particulate and microbiological monitoring of processing and manufacturing areas including a corrective action plan when levels are exceeded. A comprehensive set of monitoring locations shall be developed on the basis of experience of where contamination has actually been found in the past, likely to occur and non-viable particulate counts obtained in validation. Quality Management and Personnel: Active participation by senior management in establishing and maintaining an effective quality system is essential. Management is to establish the quality policy and quality objectives. A quality manual is a living document prepared by management that articulates the quality principles of the corporation. A regional regulatory requirement necessitates an overall structure that has a quality unit independent from production units and reports to the highest level of the organization. Laboratory Controls and Stability Studies: Quality control is a function of the independent quality unit and is responsible for all laboratories testing of raw materials, stability studies and complaint samples. There shall be approved procedures for sampling, testing, instrument operation, maintenance and calibration, acceptance and rejection of materials and recoding and storage of collected data. The stability characteristics shall be monitored as per ICH guidelines. Storage and Distribution: Ensuring adequate storage control and segregation of incoming materials, intermediates, quarantined products, controlled substances, products for release and released products for distribution is required. Also it is important to ensure that the product is stored and transported as per label claim. Some products may require specific conditions like cold chain control or protection from light.

Training: Training employees on site is probably the most important way to ensure a successful execution of a Quality System. A good and comprehensive training in the required procedures is imperative to make sure that you implement a quality mindset with all employees. Conclusion The foremost issue in designing and implementing a pharma compliant system is the provision of solid, meaningful documentation that is respectful of the user requirements and resulting design specifications. The documentation must be supportive of the commissioning and qualification testing that is performed on the system following implementation. The documentation must be highly structured and well-organized. A high degree of linkage must exist between the various design documents and engineering deliverables. Good engineering practices must be followed with regards to design reviews, management of change, and overall traceability of the design so as to produce process designs and system software that meet specification that are thoroughly documented and are fully capable of being validated. References: 1. US Food and Drug Administration. PAT guidance for industryâ&#x20AC;&#x201D;a framework for innovative pharmaceutical development, manufacturing and quality assurance 2. Rathore, A.S., Sharma, A. & Chillin, D. BioPharm Int.19, 48â&#x20AC;&#x201C;57 (2006). 3. h t t p : / / w w w. f d a . g o v / o c / g u i d a n c e / gmp.html 4. http://www.fda.gov/cder/OPS/PAT.htm. 5. ASTM Int'l 6. http://www.fda.gov/cder/guidance/ cGMPs/default.htm. 7. http://asq.org/fdc/2006/02/cgmpcompliance-trends-an-industrypersepctive.ppt 8. http://www.ich.org 9. http://www.picscheme.org 10. http://www.who.int/about/en/

Contact: lbrr@nnepharmaplan.com Pharma Bio World

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Ad Template 01.indd 11

23-11-2013 21:35:06

interview

D R VILLO O M ORAWALA PATEL L

“Innovation has been the mainstay of the company.”

20 March 2014

final interview.indd 20

Dr Villoo Morawala Patell, Chairman and Managing Director, Avesthagen in an interview with Ananya Sen discusses Avesthagen’s spine: “innovation”. Why did you choose an innovation oriented model to run your organisation? It’s like asking why you need water to survive. Innovation and free thinking is my calling. It’s in my blood and in my genes. I cannot be boxed in by any system. I have it in me to think out of the box and see connected dots that most people cannot see. In your relentless effort to build the company how difficult has it been to constantly raise funds to sustain research? It’s been a challenging and extremely interesting ride. I have had amazing, fascinating experiences where I held the world in the palm of my hand and yet have also seen depths of despair. You have always pointed out a gap between the ongoing academic and industrial research in India. How do you visualise to bridge it? I see progress on this front. And there is some exciting science coming along in some of the Institutes and they are reaching out to Industry and Industry is also interacting. However much more needs to happen. The incubation culture is very temporary and has to acquire depth. There have to be more long term sustainable

models. We must create a larger inclusive group of contributors across the space. Today we form exclusive cozy clubs, Bengaluru club, Hyderabad club, Mumbai club. We are not united and inclusive. Please share your comments on the current Indian regulatory framework for approval of biosimilars and carrying out their trials. I think the issue is of trust. We have to regain the trust of people and also carry out the trials as per the guidelines. There have been too many short cuts by the Industry and the lack of transparency has created the stalemate we see now. The regulatory framework is in place and is sensible. It is Industry that has to stop the way it does business constantly seeking short cuts instead of following the proper process. And the regulatory authorities have to be honest and transparent and give all companies big and small the same fair chance and provide critical advice and reduce the bureaucracy. The Avestagenome Project was said to be shelved for sometime due to lack of capital. How is it progressing currently? The Avestagenome Project is very much alive and work is in progress and data is being analyzed as we speak. We do not want to release any information too early. Pharma Bio World

18-03-2014 17:51:41

Ad Template 01.indd 17

23-11-2013 21:37:59

interview What are your expectations from this Project? How will it benefit to pave the way ahead? The Project has important data to put out into the world and we believe that it will herald the creation of some of the most important personalised medicine pipelines of novel biomarkers and NBEs. Since innovation has remained the central dogma of your company, do you see any other way of rewarding it besides patent? How best do you think can the issue of affordable medication especially personalised medicine be addressed in a country like India?

Innovation has been the mainstay of the company and the patents have been now converted to products and the products are soon going into clinical trials, manufacturing and sales and marketing in the next 5 years therefore generating revenues and profits for the investors. Taking personalised healthcare to the patient through a point of care approach is the best way. Avesthagen has recently signed an agreement with Elpen Pharmaceuticals to market AVDESP in some European countries. What will be your expectations in terms of revenue from this deal?

Ye s E l p e n P h a r m a d e a l w a s f o r t h e Balkan countries. The matter of revenue is confidential at the moment and we cannot divulge further details. Are you looking forward to having more of such marketing alliances in other markets? Yes we are looking at other marketing alliances from different parts of the world. Please brief us on AvesthagenPharma’s product pipeline. The pipeline is of around 8 Biosimilars for CKD, autoimmune, Cancers.

FORM IV Statement about ownership and other particulars about newspaper PHARMA BIO WORLD to be published in the first issue every year after the last day of February 1. Place of Publication

Mumbai

2. Periodicity of its Publication

MONTHLY

3. Printer’s Name Nationality 1 [(a) Whether a citizen of India? (b)If foreigner, the country of origin] Address

MAULIK JASUBHAI SHAH INDIAN YES NOT APPLICABLE 1100, Shanudeep, 10, Altamount Road, Mumbai 400 026

4. Publisher’s Name Nationality 1 [(a) Whether a citizen of India? (b)If foreigner, the country of origin] Address

MAULIK JASUBHAI SHAH INDIAN YES NOT APPLICABLE 1100, Shanudeep, 10, Altamount Road, Mumbai 400 026

5. Editor’s Name Nationality 1 [(a) Whether a citizen of India? (b)If foreigner, the country of origin] Address

Ms. MITTRAVINDA RANJAN INDIAN YES NOT APPLICABLE 26, Maker Chambers VI, Nariman Point, Mumbai 400 021

6. Names and Addresses of individuals who own the newspaper and partners or shareholders holding more than one per cent of the total capital

JASUBHAI MEDIA PRIVATE LIMITED 26, MAKER CHAMBERS VI, NARIMAN POINT, MUMBAI 400 021 Jasu Ramniklal Shah, Maulik Jasubhai Shah, Maulik Business Services Pvt. Ltd, (1100, Shanudeep, 10, Altamount Road, Mumbai 400 026), Jasubhai Business Services P Ltd., (26, Maker Chamber VI, Nariman Point, Mumbai 400 021

I Maulik Jasubhai Shah, hereby declare that the particulars given above are true to the best of my knowledge and belief. Date: 15 th February 2014

22 March 2014

final interview.indd 22

Signature of Publisher

Pharma Bio World

18-03-2014 17:52:29

Ad Template 01.indd 27

25-11-2013 11:12:31

Pulsatile Drug Delivery: A Leading Advent to Chronopharmacotherapy Unlike controlled drug delivery systems that provide constant drug levels over an extended period of time, Pulsatile Drug Delivery System (PDDS) releases the drug rapidly and completely after a lag time. The main advantage of PDDS is that it can be used to treat diseases that mainly follow circadian rhythms.

ulsatile Drug Delivery System (PDDS) is defined as the rapid and transient release of drug molecules within a short time period immediately after a predetermined off-release period, i.e., lag time. It can show an ideal sigmoidal curve or delayed release after initial lag time. The term Chronopharmacotherapy can be split in to chronopharmacology and chronokinetics. Chronopharmacology involves the study of the effects of the drugs as a function of biological timing whereas chronokinetics refers to rhythmic changes in bioavailability, absorption, distribution, metabolism and excretion of drug. The diseases that can be justified by the PDDS include Asthma, Allergic rhinitis, Rheumatoid arthritis, Osteoarthritis, ulcers, myocardial infraction, hypercholesrolemia.

biological tolerance where usually demands the prevention of drugs continues presence in at the biophase which cause decrease in the therapeutic effect. 3. F o r t h o s e d r u g s w h i c h u n d e r g o degradation in gastric acidic medium and those drugs which irritate gastric mucosa and showing side effects like nausea and vomiting. 4. For targeting a drug to distal organs of GIT, where the prevention of the drug release in the upper two third portions is the basic requirement. 5. P D D S w i l l c o m f o r t t h o s e d r u g s that undergo extensive first pass metabolism.

Conditions that Demand PDDS:

PDDS are generally classified in to time controlled and site specific delivery systems.

1. During the cases of bronchial asthma, myocardial infraction, angina pectoris, r h e u m a t i c d i s e a s e , u l c e r, a n d hypertension where they usually display time dependence. 2. PDDS can give a promising platform for those drugs which produce

Various Approaches of PDDS:

The release from the first group is primarily controlled by the system while the release from the next one is by the biological environment in the gastro intestinal tract such as pH or enzymes.

Dr. N.Kanaka Durga Devi Assistant Professor, K.V.S.R Siddhartha College of Pharmaceutical Sciences

B.Sai Mrudula Research Associate,K.V.S.R Siddhartha College of Pharmaceutical Sciences 24 ď&#x201A;&#x192;March 2014

Pulsatile.indd 24

Figure 1: Drug release profile of Pulsatile Drug Delivery System

Pharma Bio World

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requirement for pulsatile drug delivery the solubility of the drug candidates can be modified. ➢ Tablet based systems: 1. S y s t e m s w i t h e r o d i b l e o r s o l u b l e coatings: In these systems the drug release is controlled by the dissolution or erosion of the outer coat which is applied on the core containing the drug. The lag time can be varied by varying the thickness of the outer coat. In this system two subtypes are included. They are time clock system and chronotropic system. Figure 2: Time controlled system

PDDS methodologies can be broadly c l a s s i f i e d i n t o t h r e e c l a s s e s . Ti m e controlled, Stimuli controlled and Externally regulated systems.

slider partition after a certain lag time. The lag time can be altered by modifying the thickness of the semi permeable layer and use of different non swellable separators.

A.Time Controlled Systems:Here the drug will be released only after a specified predetermined time. These include single unit and multiple unit pulsatile systems.

3. Capsular systems based on expandable orifice: This is mostly recommended for liquid formulations and these liquid formulations mostly favour delivery of insoluble drugs and certain macromolecules such as polypeptides and polysaccharides.

a) Single unit pulsatile systems:In these systems the drug is released at a time following a predetermined lag period consisting of capsular and tablet based systems and implants. ➢ Capsular based systems: 1. Capsular system with a swellable plug: It consists of an insoluble capsule body with drug and swellable plug. Usually the outer capsule body is coated with ethyl cellulose in order to render it impermeable. The moulded hydrogel plug seals the drug contents within the capsular body. 2. Capsular system based on osmosis: It contains a gelatin capsule coated with a semi permeable membrane, an insoluble plug or a non swellable slider partition and an osmotic charge with in the capsule shell. On contact with aqueous media, water diffuses across the semi permeable membrane resulting in an increased inner pressure and causes ejection of the plug or 26 March 2014

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4. Delivery by a Series of Stops: This system is described for implantable capsules. The capsule contains a drug and a water-absorptive osmotic engine that are placed in compartments separated by a movable partition. The pulsatile delivery is achieved by a series of stops along the inner wall of the capsule. These stops obstruct the movement of the partition but are overcome in succession as the osmotic pressure rises above a threshold level. The number of stops and the longitudinal placements of the stops along the length of the capsule dictate the number and frequency of the pulses, and configuration of the partition controls the pulse intensity. 5. P u l s a t i l e d e l i v e r y b y S o l u b i l i t y modulation: The pulsed delivery can be based on drug solubility for any of the drug candidates. Some drugs are freely soluble where as some are sparingly soluble and can even be insoluble. Depending on the

2. S y s t e m s w i t h r u p t u r a b l e b a r r i e r coatings: Here the core is coated with a rupturable membrane and it usually ruptures due to the pressure developed by the swelling agents or osmotic agents or effervescents that are present within the core. ➢ Implants: These are drug delivery systems that are usually placed subcutaneously by a large bore needle, pellet injectors or minor surgery. 1. Bulk-eroding systems: An example would be an implant of an antigen consisting of a compressed core of antigen in Emcompress® coated with a Eudragit S100 (enteric coated polymer) then a blend of PLGA: ethylcellulose (EC). Penetration of water through the coating is dependent on the degradation of the PLGA and subsequent formation of pores, which delay it by 60–90 days before the release of a model antigen (vitamin B12). 2. Surface-eroding systems: Poly (ortho) ester and polyanhydride polymers are used in these systems as they show surface eroding property. Pulsatile release of a model protein (lysozyme, molecular weight 14 000) has been described by incorporation into poly (ortho ester) matrices. The in vitro release of model low-molecular weight dyes, brilliant blue and carboxyfluorescein, in two pulses, one Pharma Bio World

18-03-2014 18:04:41

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immediately and the second after 2 weeks was also demonstrated. The release took place through a device that was cylindrical in shape and consisted of a compressed core of drug in a fast-eroding polyanhyride. b) Multiple unit pulsatile systems:These releases the drug in more pulses and these are more advantageous than the single pulse systems as they involve no risk of dose dumping. They also offer advantages such as decreased intra and inter subject variability showing flexible release patterns. B. Stimuli Controlled Systems:These are intelligent drug delivery systems, demonstrating an ability to sense external environmental changes, judge the degree of external signal, and release appropriate amounts of drug. These systems show release of the drug after stimulation by a biological factor like temperature or any chemical stimuli. These are said to be closed loop delivery systems that means they respond to changes in local environment such as presence or absence of a specific molecule and there fore self regulating. a) Thermo responsive hydro gel systems: These follow the principle of the temperature induced systems. They show swelling and deswelling phases in response to the temperature modulations.

Figure 4: Drug carriers that work on stimuli controlled and externally regulated systems

b) Chemical stimuli induced pulsatile systems: In case of diabetes mellitus there is rhythmic increase in the levels of glucose in the body requiring injection of the insulin at proper time. Several systems have been developed which are able to respond to changes in glucose concentration. One such system includes pH sensitive hydrogel containing glucose oxidase immobilized in the hydrogel. When glucose concentration

in the blood increases, glucose oxidase converts glucose into gluconic acid which causes a change in the pH of the system. c) I n f l a m m a t i o n - i n d u c e d p u l s a t i l e systems: On receiving any physical or chemical stress, such as injury, fracture etc., inflammation takes place at the injured sites. During inflammation, hydroxyl radicals are produced from these inflammationresponsive cells. In pH sensitive drug delivery systems such type of pulsatile drug delivery system contains two components one is of immediate release type and other one is pulsed release which releases the drug in response to change in pH. C. Externally Regulated Systems:These are said to be open loop systems which are not self regulating and require externally generated changes like magnetic fields, ultrasound, electric field, light and mechanical forces to initiate drug delivery.

Figure 3: Stimuli controlled system

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There are many drug carriers that work on the principle of stimuli controlled and externally regulated systems. These Pharma Bio World

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drug carriers are mainly Nanomaterials. Nanomaterials have a relatively larger surface area which can make materials more chemically reactive and they s h o w i n c r e a s e d q u a n t u m e ff e c t s l i k e optical, electrical and magnetic behavior of materials. Other targeting drug carriers: • Dendrimers • Liquid crystals • Nanoparticles • Nanoclinics • Nanoshells • Cantilevers • Quantam dots ➢ Micelles: Micelles are nanomaterials formed by self assembly of amphiphilic block copolymers of size range of 5-50 nm in aqueous solutions. Here the drugs are physically entrapped in the core of block copolymer micelles. 1. Thermo sensitive micelles: A very elegant approach to improve temporal control involves the use cross linked of block copolymers where one of the segments possesses a lower-critical solution temperature (LCST). Below t h e i r L C S T, p o l y m e r s s u c h a s p o l y (N-isopropylacrylamide) (PNIPAAm) are water-soluble, while raising the temperature of an aqueous solution above the LCST results in phase separation. These are said to be thermo sensitive micelles. 2. Ultrasound-responsive micelles: Another approach to improve temporal control was ultrasound-responsive micelles. One of the examples is the PLAb-PEG copolymer micelles prepared by Hongji Zhang et al. The release behavior of these micelles is based on the applied High intensity focused ultrasound (HIFU). They prepared biodegradable PLA-b-PEG copolymers and self-assembled them into spherical micelle in aqueous solution. They used hydrophobic Nile Red, as a payload model to examine the release behavior of the micelles. They found that the release behavior of encapsulated Nile Red was triggered by HIFU. Pharma Bio World

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➢ Liposomes: Liposomes are small artificial vesicles of spherical shape that can be produced from natural nontoxic phospholipids and cholesterol. Because of their size, hydrophobic and hydrophilic characters and biocompatibility, liposomes are promising systems for drug delivery. 1. Enzyme sensitive liposomes: The hydrogel matrix which is hydrophilic was designed to protect the liposomes from degradation. To achieve a pulsatile release of drug molecules the liposomes inside the microcapsules are coated with phospholipase A2. Phospholipase A2 is known to gather at the water/liposome interfaces and remove an acyl group from the phospholipid in the liposome, resulting in the destabilization of the liposome which results in release of the drug molecules from the interior, thus allowing drug release to be regulated by the rate determining microcapsule membrane. 2. Ultrasound-responsive liposomes: Echogenic targeted liposomal complex can incorporate drugs and deliver them directly to cells. Rhodamine-labeled echogenic liposomes (Rh-ELIP) containing nanobubbles are delivered to the arterial wall, to check whether 1-MHz continuous wave ultrasound enhances the delivery profile. ➢ LIMs: Liposomes-in-micro sphere (LIM) made of biodegradable polymers, is conceived from a combination of the polymer and the lipidbased delivery systems and can integrate the advantages and avoid the drawbacks of the two systems. They demonstrated that a decrease in the particle size of liposomes and increase in the pore size of the polymeric matrix shortened the initial offrelease period and increased the liposome release rate.

core, branching units and terminal functional groups. The core chemistry determines the solubilizing properties of the cavity within the core, whereas external chemical groups determine the solubility and chemical behavior of the dendrimer itself. Targeting is achieved by attaching specific linkers to the external surface of the dendrimer which enable it to bind to a disease site, while its stability and protection from phagocytes is achieved by decorating the dendrimers with polyethylene glycol chains. ➢ Liquid Crystals: Liquid Crystals combine the properties of both liquid and solid states. Liquid crystals can be made to form into different geometries, with alternate polar and non-polar layers (i.e., lamellar phases), within which aqueous drug solutions can be incorporated. ➢ Hydrogels: Hydrogels are three-dimensional polymer networks that swell but do not dissolve in aqueous media. They are said to be carriers of swelling-controlled based. 1. Thermo sensitive hydrogels: PIPAAm cross-linked gels are one of the examples of hydrogels that have shown thermoresponsive, discontinuous swelling and deswelling phases. Further a similarly rapid deswelling phase was achieved by incorporating poly ethylene glycol (PEG) graft chains into PIPAAm cross-linked hydrogels. 2. Enzyme sensitive hydrogels: Yui et al. recently reported the development of a new drug delivery device based on hydrogel. They tested the drug release form PEG-grafted dextran gel combined with an ungrafted dextran gel in a multi-layer structure located within an impermeable silicone tube exhibiting an open end at both sides. ➢ Nanoparticles:

➢ Dendrimers: Dendrimers are nanometre-sized, polymer macromolecules. They consist of a central

These include nanoclinics, nanoshells, cantilevers, polymeric nanoparticles, nanocrystals. March 2014 29

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1. Nanoclinics: These are one of the multifunctional Nanodevices, which mostly help in targeted drug delivery. Until now these were used as a successful approach in killing malignant cells. 2. Nanoshell: These are nanodevices that consist of core of silica and a metallic outer layer of usually gold. By manipulating the thickness of the layers making up the nanoshells, the beads can be designed that absorb specific wavelength of light and mostly they absorb near infrared region light that can easily penetrate several centimeters in human tissues. Absorption of light by nanoshell creates an intense heat that is lethal to cells. Because of their size nanoshells will preferentially concentrate in cancer lesion sites due to the EPR (Enhanced permeability and Retention effect). 3. Cantilevers: They are microfabricated drug delivery devices that consist of tiny bars usually made of silicon built by the semiconductor lithographic techniques. These can be targeted toward specifically expressed proteins of the tumor cells. As cancer cells secrete its molecular products, the antibodies coated on the Cantilever fingers selectively binds to these secreted proteins. Thus the selectivity of these cantilevers is more and the drug can be easily administered to the targeted cells. ➢ Hydrogel nanoparticles: Hydrogel nanoparticles have gained considerable attention in recent years as one of the most promising nanoparticulate drug delivery systems owing to their unique potentials via combining the characteristics of a hydrogel system with a nanoparticle. ➢ Molecularly Imprinted Polymers (MIP): Molecularly imprinted polymers have an enormous potential for drug delivery systems. By following the MIP technology the drug delivery can be modulated to rate programmed drug delivery, where 30 March 2014

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drug diffusion from the system has to follow a specific rate profile or activation modulated drug delivery. The release is either activated by some physical, chemical or biochemical processes or is due to feedback regulated drug delivery, where the rate of drug release is regulated by the concentration of a triggering agent, which is activated by the drug concentration in the body. ➢ Microelectromechanical Systems (MEMS) : The delivery systems under this category work either on the basis of implantable technology or are oral delivery systems or injectable. Microfabrication techniques are used to produce these MEMS. 1. Neural implants: These are used for neural stimulation, recording of neural activities. The system consists of the surgically implanted module, an external computer system that is used by the physician to program the module through induction, and an external switch that the patient uses to activate the device. 2. Drug-coated stents: Stents are one method by which the size of arteries can be increased in patients with heart disease and narrowing of the arteries. These are also implantables. But these have certain disadvantages like hyperplasia and restenosis. One novel approach that has been suggested for improving the performance of stents and decreasing the incidence of restenosis is to use microfabricated silicon microprobes to deliver therapeutic agents to the arterial wall. 3. Micro reservoirs: These devices could be used for oral drug delivery, with release of the drug triggered by binding of a surface-functionalized molecule to cells in the digestive tract, or the devices could be injected for intravenous distribution. 4. Mini and micropumps: Minipumps offer greater temporal dosing flexibility and reduction of instability and hypoglycemia

to patients who are poorly controlled with subcutaneous insulin injections or have recurrent hypoglycemia. 5. Biosensors: Sensors are implantables and one of the components of MEMS based integrated drug delivery systems. Sensors are mainly used for monitoring pH, analytes, and pressure of tissues, blood, and body fluids where as Immunosensors are used in a variety of medical diagnostic tests to analyze clinically important analytes that are often present in very low concentrations. The main principle involved with these immunosensors was binding interactions between an antibody and antigen which results in detectable signals. ➢ Meshes: These are multilayered drug loaded biodegradable nanofiber meshes that enable time-programmed dual release in a single formulation using sequential electrospinning. It consists of first drug loaded mesh (top), barrier mesh, second drug loaded mesh and basement mesh (bottom). They have some unique features such as a high surface-area-to-volume ratio, flexibility of morphological designability, and an extra cellular matrix-like structure. They demonstrate the time programmed drug release by using these multilayered electro spun nanofiber meshes. Conclusion I n t h e p r e s e n t r e v i e w, w e d e s c r i b e d the various approaches for pulsed drug delivery systems. Various drug carriers can be modulated to better disease markers and immunological and toxicological screeners by flexible engineering of various polymers and hydrogels which help in passive and active targeting of the disease sites and also nourish pulse drug delivery pursuing Stimuli and External regulated concepts. Thus combined approach of drug carriers with sigmoidal and controlled release concepts of PDDS put together the benefit of targeting as well as pulse release. Contact: nelluriss@rediffmail.com Pharma Bio World

19-03-2014 16:30:13

The Development of Single-Use Aseptic Processing Systems Though the connecting device or connection method may appear to be a small part of an overall system, connection and disconnection of tubing for process fluid transfer is a critical aspect of single-use processing, and manufacturers need to carefully consider the available options because the connector can be the deciding factor in keeping the single-use bioprocess truly aseptic.

John Boehm Bioprocessing Business Unit Manager Colder Products Company

Pharma Bio World

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o d a y ’s h i g h m a r k e t d e m a n d f o r biologic and pharmaceutical products challenges bioprocessors to review their processing systems and seek ways to make them more flexible, reliable and cost effective, and as a result, more manufacturers are turning to single--use manufacturing, which provides a number of advantages from lowering operating costs and reducing contamination risks, to improving production yields and increasing process flexibility.

Examples and case studies of single-use technology in use have also become more common. The aforementioned benefits have led to strong adoption of single-use manufacturing by major biopharmaceutical manufacturers throughout the United States and Europe for nearly 20 years;

Below is a list of benefits that single-use offers: • Economic Advantage - reduces capital requirements for new facility builds or retrofits of existing facilities and smaller facility footprints are possible. • Safety/Quality – reduction of cross contamination risks and improvements in sterility assurance not only reduce product loss but make it easier to produce multiple products within a single facility. • Speed to Market - shorter facility builds and reduced validation cycles support the challenge of developing and introducing new therapies (critical in all segments but even more important in the race to develop biosimilars). • Operational Efficiencies – these include reduced cleaning requirements and labor costs, faster product changeover, and reduced downtime. • Operational Flexibility – the ability to run multiple drugs in the same facility or quickly convert for product or campaign changeover is possible. • Sustainability - less energy, chemicals and water are expended than traditional stainless systems.

Shire, for instance, has been quite successful in a business strategy that leverages a platform of specialty biopharmaceuticals that include a broad range of smaller revenue drug therapies. The flexibility of singleuse allows them to produce a wide range of products in flexible facilities based on single-use manufacturing. A noted highlight of their activities includes building and commissioning a new world-class facility in only two years, versus a traditional stainless facility which typically takes five years or more.

adoption is also increasing throughout Asia. Here are some notable examples of companies basing their manufacturing on single-use:

Catalent Pharma Solutions is an example of a contract manufacturer that requires the flexibility and sterility assurance to produce an ever-changing range of products for a variety of different clients. They continue to replace stainless-based processes with single-use processing equipment. They also took advantage of the speed of implementing single-use technology to retrofit an empty building into a multi-cleanroom facility in approximately one year. In Singapore, Amgen is in the process of building and commissioning a new facility of the future based on single-use technologies.

With the evolution of single-use system design came the introduction of Steam-in-Place connectors that allow a sterile connection to be easily and reliably made between stainless processing equipment and single-use bags and tubing assemblies. March 2014 31

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•

There are many more examples of global drug manufacturers presently working on projects to implement closed modular system designs that drive increased volumes to lower costs and increase process flexibility while maintaining or increasing sterility assurance. Increasing demands of single-use technologies mean that there needs to be robust supply that offers customers greater choice. There is a full range of different single-use connection technologies available, depending on the customer’s applications and specific needs. Solutions range from basic quick connects and fittings to advanced steam-in-place (SIP) and sterile connectors. When the first single-use bags transitioned from the blood market into biopharmaceutical applications nearly 20 years ago, plastic quick connects and fittings were utilised to connect these early systems. These MPC and MPX connectors have become an industry standard and are still widely accepted throughout the industry to make aseptic connections under a laminar flow hood. The introduction of new additions to these product families including back-to-back adapters solve the issue of connecting two male connector halves or two female connector halves. These adapters can also easily connect systems with different tubing diameters. With the evolution of single-use system design came the introduction of Steam-in-Place (SIP) connectors that allow a sterile connection to 32 March 2014

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be easily and reliably made between stainless processing equipment and single-use bags and tubing assemblies. SIP connections are a critical tool to help drug manufacturers utilise existing stainless equipment while benefiting from the advantages of single-use through the creation of hybrid systems. Further developments have created a range of sterile connect and disconnect technologies for tubing and related applications which are easy-to-use, robust sterile connections for applications from small flow 1/8” tubing for sampling bottles and cell culture bottles and trays to large flow 1” tubing applications. These include single-use bio reactors, mixers and disposable filling systems. Nowadays a one-time sterile disconnect of pre-sterilized systems for applications like buffer preparation and filter integrity testing is also available. Besides, other offerings include a range of solutions that combine SIP, sterile connect and sterile disconnect combinations to further ease the configuration and integration of single-use systems. With so many choices offered, there are a number of key factors to consider when choosing the correct connection solution; they include: • Ease of use – this is a critical factor in minimizing operator error and assuring repeatable and reliable performance.

•

Robustness – robustness is a must to assure product quality and customer confidence. Process scale –appropriate solutions for the flow and pressure requirements of a particular application should be considered. Material compatibility – meets sterilization and chemical compatibility along with appropriate extractable profiles. Existing equipment – compatibility with existing processing equipment is especially important for hybrid systems that combine stainless and single-use processes. Available solutions – customers need to be aware of the full range of solutions available. Past validation work/validation materials – potential time savings achieved by using validation work previously completed by a global validation team or another corporate facility should be considered. Vendor reputation – the manufacturer’s expertise in connection technology to provide the required technical support is an important factor.

After the solution has been chosen and installed, there are several strategies to support customer validation, including utilizing vendor validation testing data for product performance and extractable, etc. Many customers are working to validate products once for global approval across all their facilities, which are often supported with technical support from the vendor including FMEA evaluations. Users can also reference BioProcess System Alliance (BPSA) Quality Test Matrices for single-use connectors to gain valuable technical references over best practice component tests. To conclude, connection technology has certainly advanced in recent years and continued innovation is expected. This will enable the growth of aseptic processing by providing the ease of use, reliability and sterility assurance required by connections in support of advanced single-use systems. Contact: john.boehm@colder.com Pharma Bio World

20-03-2014 13:00:25

Expanding Your Business Development Strategy with Smart Competitive Intelligence Rapid development in innovation and technology has made the bridges between different business areas shorter, while simultaneously making the competitive landscape larger. There are few industries where that is more evident than pharma.

mart Competitive Intelligence professionals are stepping out of their traditional boundaries and rethinking the way they work with the rest of the business. These pioneers are engaging with the problems that the business needs to solve, like how to enter a new geography, how to predict the trajectory of a new drug launch or maximize the revenue from an end-of-patent-life drug, and are using information about competitors to do it. This is not industrial espionage, it’s being smart about bringing together publicly available information from myriad sources and analyzing it to find the trends and patterns that help decision makers formulate their strategies. There’s a term for this activity: Big Data. The application of Big Data tools and techniques for these problems has become the newest advantage in analytics for several companies. It’s daunting to consider the amount of information that can, should or needs to be collected before smart decisions can be made about how to proceed—What is the competitive landscape of the product? What’s happening in the public or private sectors that could affect this decision? What’s the latest regulatory news, if any? How does the global landscape look? Who is talking about this product/innovation/idea, what are they saying and why? What’s the latest research and who are the key opinion leaders? What are patients talking about on Social Media? Honestly, the list could go on. But you know most of these questions already. The real question is: How can I get all this information in a way that doesn’t drain my resources? Most businesses have collected information— either intuitively or practically—about their

Tim Miller Vice President-Product Management and Analytics Thomson Reuters Life Sciences Pharma Bio World

Expanding Your Business.indd 33

own landscape, looking “inside out”. They know their strengths and weaknesses. They understand how they’re viewed in the overall marketplace. They know what makes the numbers spike, and what makes them fall. But that should only be half of your business development strategy. The other half is working “outside in”: knowing these things about your competitors, especially if they know them about you. Getting a grip on your competitive intelligence strategy through intelligently designed data analytics means reducing your reliance on manual research, monitoring your competitors efficiently and effectively, and understanding your competitors’ marketing strategies, including pricing, inventory and outreach. Not only will you improve your process in cultivating existing opportunities, you’ll also come across those that have yet to be discovered. If it was tough in the old days to keep up with all this information, then today it’s virtually impossible. So much information, so little time and so little resources— unless you embrace the data management and analytic tools coming out of the Big Data revolution and factor them into your business development equation. Manual research isn’t just impractical; it’s a surefire way to miss the data you need to make your business stronger. There are only so many keywords you can type into Google Analytics until your required searches reach into the thousands and render themselves pointless. You could never uncover everything you need to know. Not in this day and age. All this is well and good—but how do you start? Here’s how: Develop a plan. Start small, don’t try and “boil the ocean” in one go.

Manual research isn’t just impractical; it’s a surefire way to miss the data you need to make your business stronger. March 2014 33

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Visual analytics can make content more accessible and easier to integrate into drug development workflow.

Align your thinking with the business’s objectives, mission and goals. What is the business trying to do right now? How can competitive intelligence help? What do you already know about what current and prospective competitors are doing in the same space? What do you want to know? There’s a lot of information out there; it’s not called “Big Data” for nothing. The competitive intelligence data you need for one business opportunity will look very different from another.

Know what you want to do with the information. With competitive intelligence, you’re working in a somewhat backward fashion: You need to know in what format you need to deliver the end results before you can start. So, what are you going to do once you have the information? How do your customers prefer to receive it? What are they most likely to want to do five minutes after receiving it, how do you support that “so what” next step?

Find out how you will gather and mine this information. Remember: You want an analytics system that is designed intelligently, with the pharma and bio world in mind. You want to do business with a company that knows and understands the data analytics business and has a solid understanding in the evolution of Big Data.

U n d e r s t a n d t h a t t h i s i s y o u r s t o r y, not theirs. Gathering competitive intelligence helps you tell your own story. It’s not about exposing the weak underbelly of your rivals; it’s about knowing your rivals well enough that you understand your strengths, and how to share those strengths on a wider landscape.

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Stay current. Competitive intelligence isn’t a one-stop fad. It’s something that requires your continued attention. Creating and implementing an effective competitive intelligence plan can be a time consuming process. How can this be done while doing all the tasks that a Pharma Competitive Intelligence professional needs to do? For those with the time and the technical ability, there is a lot that can be done by “rolling your own” – doing the analytics yourself. On the other hand, many organizations offer services to build analytics for you. The best solution is probably a mix of both. Pick the analytics that best fit your core competencies, and do these yourself; then, get help with the rest. That way you can build your own skills in the long term without being overwhelmed in the short. Contact: jennifer.breen@thomsonreuters.com Pharma Bio World

20-03-2014 13:08:42

Moving From Batch to Continuous: Striving For Greater Efficiency in Pharmaceutical Manufacture Across the pharmaceutical industry there is a pressing need for greater manufacturing efficiency. This article considers the potential benefits of continuous processing as well as the tools that can help to achieve success.

he benefits of continuous manufacturing justify significant investment as evidenced by collaborations such as the MIT/Novartis Center for Continuous Manufacture. Batch production currently dominates within the pharmaceutical industry but within 20 years many expect that continuous processing will secure a substantial share of manufacture. This article discusses the benefits of continuous manufacture and considers how analytical practices may need to change to support new manufacturing models, highlighting the need for techniques that support intelligent processing. Dynamic powder testing is introduced as a method which can contribute to the development of efficient continuous processes. Exploring the Benefits of Continuous Manufacture

Yogin Chandorkar Assistant General Manager Aimil Limited

Jamie Clayton Operations Director Freeman Technology

success. Batch-to-batch variability and products outside the defined specifications are common problems. The associated re-work required and level of waste are considered unacceptably high. Continuous processing is widely used in industries such as chemicals and foods and offers several important advantages: • Reduced costs • Less waste • Improved asset utilization • Simplified scale-up • Better containment • Labor savings • Lower capital investment These highlight the environmental, safety and economic improvements that continuous operation brings but there are also technical benefits.

Although innovative in terms of drug d i s c o v e r y, a n d a t t h e f o r e f r o n t o f fundamental research, the pharmaceutical industry has historically focussed less on processing. Patent protection previously ensured that R&D costs could be properly recouped but as those costs rise, and times to market increase, this is no longer guaranteed. Once patents expire, profitability relies on efficient production, making this a focus for the industry. Furthermore, the regulatory focus on risk suggests a need for greater understanding of manufacturing processes and improved control of product quality. A shift from batch processes that are heavily reliant on manual intervention to automated, continuous operation is highly attractive.

A batch step has a beginning and an end; between these points the product continuously changes, e.g. a blending process starts with the unmixed constituents and proceeds to an appropriately homogeneous state. A well-controlled continuous process should operate at steady-state for the majority of the time which requires effective process monitoring, as exemplified by widely used techniques such as in-line particle size and near infrared (NIR) analysis. Steadystate operation means that continuous processing is associated with consistent output which equates to more assured product quality with less re-work or waste. Scale-up is also simplified as production targets can be met by running smaller units for longer avoiding the complications introduced by changes in equipment geometry and material volume.

In batch production, sequential process steps are undertaken, with analysis performed between each one to determine

It is also important to consider the benefits of batch production. One advantage is flexibility, as a suite of batch equipment

Pharma Bio World

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Although innovative in terms of drug discovery, and at the forefront of fundamental research, the pharmaceutical industry has historically focused less on processing. can be easily re-configured for different products. Batch production also simplifies isolation and containment of a problem. With continuous manufacture, there is a question of how to define a ‘batch’. A batch essentially becomes associated with an operating period which begins when startup completes and the product is being manufactured successfully, and ends at a defined point. Any out of specification products are therefore associated with a time period rather than a discrete batch number which can make problems difficult to isolate and rectify. Optimised processing, whether batch or continuous, relies on a comprehensive understanding and control of the materials and process variables that define clinical efficacy. The pharmaceutical industry has traditionally focused on developing and adhering to repeatable processes. This approach relies on consistent feed and provides little flexibility to respond to variation. This is a critical limitation as feed variability is a major source of failure so there is a desire to move from empirical batch processing towards knowledgebased continuous manufacture. However, there are challenges associated with this transition.

on powder flow, compressibility and other material characteristics. The Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) is one of the groups at the forefront of research in this area. Working to develop a test bed for the production of solid dosage forms, the group applies modelling skills, in-line analysis and techniques such as powder rheology, to integrate sequential blending, dry granulation, lubrication, and tableting. A key focus is to develop solutions that avoid three common issues that compromise the quality of batch produced tablets: segregation, agglomeration and compaction quality [2]. Whether improving batch processing, or introducing procedures to design, monitor and control continuous manufacturing, the industry needs appropriate analytical tools that deliver process relevant data and expand understanding of how processes work and can be improved, reinforcing the FDA’s Process Analytical Technology (PAT) initiative. There are two strands to analytical requirements. Firstly, a need for techniques that provides process relevant information that help achieve efficient

and reliable continuous production. Secondly, a requirement for intelligent and relevant approaches to process monitoring and control. PAT has become synonymous with realtime analysis but the initiative is much broader. The FDA defines PAT as ‘a system for designing, analysing and controlling manufacturing through timely measurement (i.e. during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.’ Real-time analysis is therefore important but so are techniques that, for example, provide robust analysis of feeds prior to introduction to the plant, or the use of soft sensors [3]. Focusing on information required to achieve process efficiency and identifying techniques that provide it is a pragmatic approach. Focusing on Powder Testing Tablets are the most common drug delivery vehicle and the majority of drugs are handled in solid form at some point during manufacture so this brings attention to suitable analytical tools for powder testing. Numerous methods have been developed to characterize powders including angle of repose, flow through an orifice and tapped density. These techniques are relatively simple and provide some insight into the

An Analytical Toolkit to Support More Efficient Manufacture Widely employed operations, such as milling, roller compaction and tableting, can be considered semi-continuous, as they are constantly fed during a batch campaign. The challenge involves engineering the equipment for reliable, prolonged operation and successfully integrating the necessary components into an optimized continuous process. Automation is important but so are analytical tools that provide the necessary knowledge to optimise multicomponent systems, such as information

Figure 1: Measuring flow energy is a sensitive and process relevant way of quantifying changes in flow properties as a result of consolidation, suggesting that it may be more useful than tapped density techniques in process optimization studies

36 March 2014

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Pharma Bio World

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Figure 2: Dynamic testing provides differentiation of materials that shear testing classifies as identical, providing valuable insight for process optimization studies.

A batch step has a beginning and an end; between these points the product continuously changes. nature of a powder. However, the need for accurate, process relevant data exposes limitations and highlights the merits of methods such as dynamic testing. In dynamic testing, axial and rotational forces acting on a blade are measured as it rotates through a powder sample to determine values of flow energy which directly quantify how easily a powder flows under conditions that reflect processing environments. Powders can be characterized in consolidated, conditioned, aerated or even fluidized states, to measure the response to stress and air content. The impact of moisture, flow additives, prolonged compaction, attrition and segregation can be directly assessed. Figure 1 contrasts the change in bulk density induced by tapping with the corresponding change in flow energy. The flow energy increases by an order of magnitude greater than the density suggesting that flow energy measurements are significantly more sensitive in detecting the impact of a change. Furthermore, this indicates that tapped density could be misleading in terms of quantifying how consolidation might impact a process.

This experiment emphasises the importance of selecting a suitable analytical technique for a given application. It is increasingly acknowledged that no single powder testing method is ideal for every application but that a test should represent the conditions that the material will be exposed to. Shear testing, for example, is a wellestablished technique that was developed to support hopper design protocols. It is still applied in this arena, with modern instrumentation delivering i m p r o v e d r e p r o d u c i b i l i t y, a n d i s a valuable tool for characterising powders in a static, consolidated state but there are limitations.

Looking Ahead The rise of continuous manufacture, and the associated drive for greater processing efficiency, increases the need for relevant analytical techniques that support intelligent process design and enable effective process monitoring and control. It is essential to consider what information is required and identify how best to obtain it. Applying this approach to powder characterisation highlights limitations with traditional techniques. Innovative techniques such as dynamic testing and in particular, instruments that combine dynamic testing with other methods such as shear and bulk property analysis, present an efficient and versatile choice for those driving pharmaceutical processing to new levels of efficiency. References:

Figure 2 shows shear and flow energy data for two common excipients, vanillin and ethyl vanillin. Shear testing characterizes these materials as identical while dynamic testing indicates varying properties. As the flow energy measurements demonstrated correlation with in-process behavior, these results indicate that materials classified as identical by shear testing may actually process differently. This highlights the importance of employing a method that closely simulates the conditions in a given process.

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[1] Reuters, "Drugmakers warn of $140 billion patent 'cliff'" (2007). http://uk.reuters.com/ article/idUKGRI22300720070502 [2] Test bed 1 plan from the C – SOPS website. http://ercforsops.org/Display/General. aspx?CategoryId=11 [3] N. C. Chakrabarti ‘Virtual sensors for advanced pharmaceutical control’ h t t p : / / w w w. p h a r m a m a n u f a c t u r i n g . c o m / articles/2006/063.html

Contact: info@freeemantech.co.uk March 2014 37

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market research

Need for Innovation in the Global Pharma Industry Frost & Sullivan gives an insight into the current R&D trends and the expenditure incurred on them in the pharmaceutical industry globally. Dr E Saneesh, Research Analyst,

Business & Financial Services – Healthcare Frost & Sullivan

he global pharmaceutical industry has witnessed decreased growth in profitability over the past few years. The global economic slump, expiry of blockbuster drug patents, increasing generic competition, efforts to contain public spending on drugs globally, and growth in the number of companies competing for the same profit pool are key factors responsible for decreasing profitability of major participants in this industry. Along with this, increasing costs in drug production, selling, and marketing has created a negative impact on previously high profit margins. Moreover, major drug companies believed that investing in emerging economies would accelerate revenue growth. This has proved to be a myth as economic slowdown, progeneric governments, domestic competition, and the ripple effect of price cuts has forced policy makers in emerging economies to implement price caps on key products. Key emerging economies like China have developed regulations promoting local players, thereby restricting market access with greater pricing pressures. Fizzling Innovation Model Major participants of the pharmaceutical industry are facing a two-fold crisis in terms

of innovation. The number of blockbuster drugs about to lose their patents is dismayingly high, and the pipelines of these companies are relatively empty compared to five years earlier. The expiry of patents of leading drugs had a severe impact on the sales of major pharmaceutical companies. Lipitor which was the blockbuster drug of Pfizer Inc. went off patent in November 2011, post patent expiry; it had an impact of around 18.35 per cent on Pfizer’s sales. Likewise Plavix, a platelet aggregation inhibitor, the block buster drug for Bristol-Myers, went off patent in May 2012. On patent expiry, Plavix Company Forest Laboratories

Pharmaceutical

Reduction in R&D Investments Increasing liabilities from investment in drug development coupled with decreasing returns on investment in pharmaceutical research and development (R&D) has made major market participants reevaluate their growth strategies. Major pharmaceutical companies have started to see in-house R&D as a cost centre. This is quite evident from the analysis Patent Expiry

Lexapro

Mar-12

Takeda Pharmaceutical

Actos

Aug-12

Bristol-Myers Squibb

Plavix

May-12

AstraZeneca

Seroquel

Mar-12

Eli Lilly

Zyprexa

Oct-11

Pfizer

Lipitor

Nov-11

Merck

Singulair

Aug-12

Novartis

Diovan

Sep-12

Teva Pharmaceutical

Provigil

Apr-12

Abbott Laboratories

TriCor

Jul-12

Source: Capital IQ, Frost & Sullivan Analysis Exhibit 2: Patent Expiry of Leading Drugs of Major Pharmaceutical Companies

2009

2010

2011

2012

2013

Pfizer Inc.

2.0%

32.3%

0.1%

(9.6%)

(12.5%)

Roche Holding AG

6.8%

(3.9%)

(10.3%)

7.6%

2.5%

Novartis AG

6.0%

14.4%

15.2%

(3.1%)

2.3%

Sanofi

8.4%

9.0%

3.0%

2.6%

(7.4%)

AstraZeneca PLC

3.8%

1.4%

1.0%

(16.7%)

(8.1%)

Abbott Laboratories

4.2%

14.3%

(39.1%)

0.4%

1.6%

Source: Capital IQ, Frost & Sullivan Analysis Exhibit 1: Year on Year (YOY) growth of total revenue of select pharmaceutical companies

MARKET RESEARCH.indd 38

Major Challenges Innovation

Drug

Company

38 March 2014

had an impact of around 48.0 per cent on Bristol-Myers’ sales.

of R&D expenditure of top pharmaceutical companies where total investment in R&D has increased between 2008 and 2013. However, on critical examination it is understood that the R&D to sales ratio has either remained flat or decreased between 2008 and 2013. This is because companies have realised that in-house R&D had not increased shareholder’s value in the short run. Pharma Bio World

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market research Company

2008

2013

Pfizer

15.6%

12.7%

Novartis AG

16.8%

16.0%

Roche Holding AB

18.2%

18.0%

Merck KGaA

17.0%

13.5%

Abbott Laboratories 9.1%

6.6%

Sanofi

14.3%

15.9%

Source: Capital IQ, Frost & Sullivan Analysis Exhibit 3: R&D to Sales Ratio 2008 and 2013

Regulatory Complexity Successful innovation is attainable only with the availability of intellectual capital, financial stability, and a regulatory environment conducive to quality research and protection of intellectual property. The regulatory niceties that were present for pharmaceutical R&D a decade earlier have been modified and regulations are becoming more and more stringent. The complexity of the drug development process has increased not only at the approval stage but also in the preclinical and clinical phases. Number of procedures required per trial and the number of unique procedures per trial have increased by 58 per cent and 48 per cent, respectively, between 2000 and 2011. Regulatory complexity coupled with reduction in innovation has drastically reduced the number of New Molecular Entities (NME) approved by the United States Food and Drug Administration (USFDA). The number of approved NMEs got reduced from 54 in 1996 to less than 27 in 2013.

Increasing Drug Development Costs R&D investment in the Pharmaceutical industry is highest among many research intensive industries. According to the Joint Research Center, European Commission, in 2011 R&D spend by the Pharmaceutical industry was five times greater than R&D spend by aerospace and defence industries, 4.5 times greater than the chemical industry and 2.5 times more than software and information technology industry. Increasing costs have made current R&D models in the Pharmaceutical industry more indefensible and less sustainable compared to previous decades. Productivity of pharmaceutical R&D is impacted by spiraling costs of drug development and increasing failure rates. The total failure rate also varies across stages of development. Overall failure rate increased from 87 per cent in 1990 to 92 percent in 2004. However, failure rates in phase I and phase II trials increased from 21 per cent to 32 per cent during the same period. As failure rates increase in later stages, the loss incurred is higher. The Way Out The crisis in R&D productivity has forced major industry participants to look at alternate models and strategies to reverse the decline in R&D productivity. Mergers and Acquisitions (M&A), Alliances and Open Innovation are few strategies used by industry participants to enrich their R&D pipeline. Earlier, acquisition of companies with innovative products was the key strategy adopted 2000-2003 2004- 2007

2008- 2011

Unique procedures per trial protocol (Median )

20.5

28.2

30.4

Total procedures per trial protocol

105.9

158.1

166.6

Total investigative site work burden (Median units)

28.9

44.6

47.5

Source: Tufts Center for the Study of Drug Development Exhibit 4: Clinical Trials Protocol Complexity

Pharma Bio World

MARKET RESEARCH.indd 39

Year

Big Specialty Pharma Pharma (%) (%)

Big Biotech (%)

2007 70.2

2.0

6.9

2008 15.9

24.0

1.9

2009 31.5

18.3

6.4

2010 26.1

9.5

0.0

2011

18.3

0.4

2.1

2012 32.3

4.3

10.1

2013 3.6

22.4

12.5

Source: Capital IQ, Frost & Sullivan Analysis Exhibit 5: Contribution to Deal Value by Big Pharma, Global, 2007â&#x20AC;&#x201C;2013

by large pharma companies to boost their R&D. However, increasing demand for companies with promising molecules has made the acquisitions landscape quite competitive. Moreover, the advent of big biotech companies and specialty pharma has resulted in a tremendous increase in target valuations. The contribution of big pharmaceutical companies to the total M&A deal value has reduced from 70.2 per cent in 2007 to 3.6 per cent in 2013. Open Innovation and collaborative research was a strategy by major pharmaceutical companies to make R&D programs sustainable and share liabilities in case of failures. Big pharma companies like Pfizer, GSK, Novartis, Astra Zeneca, etc. have a number of products currently in their pipeline with R&D programs with Open Innovation and Alliances. To conclude, innovation is essential for value creation and an indispensable driver of the pharmaceutical industry. To reengineer the pharmaceutical R&D engine and increase shareholder value for R&D wherewithal, pharma majors should take the lead to adopt strategies that will advocate product differentiation, capacity building in R&D, and nurture innovation through more collaborative research. Contact: akshatam@frost.com March 2014ď&#x201A;&#x201E; 39

18-03-2014 18:46:57

news features

Is India Ready for Bio Warfare? Biological weapons are more dangerous than nuclear weapons. Advances in biotechnology have renewed concerns that countries or terrorist groups might resort to using germs as weapons. This news feature emphasises on the seriousness of the threat of biological warfare and how prepared is India to handle such situation.

e have read it in science fictions. We have seen many Hollywood movies depicting it. But, what if we have to face it in real life? It is true that the threat of bioterrorism/bio warfare is real and we had seen the instances when ‘Anthrax Attacks’ occurred in America in 2001, September. killing five people and sickening 17. It was just a sample. In fact, biological weapons are capable of producing a large number of casualties. According to a startling new scientific study, a bioterrorism attack could spread to several continents before it is even detected. The study found that if a small group of terrorists infected themselves with a disease such as smallpox and walked around London, then the pathogens could spread to up to four nations before doctors managed to diagnose it. If such an attack happens in India, how well can India manage the situation? Dr Madhusudan P Dabhole, Group Manager – Bioprocess, R&D, Richcore Lifesciences Pvt Ltd, Bengaluru, says Indian biodefense sector is well prepared to fight bioterrorism/ bio warfare. The National Disaster Management Authority (NDMA) in its most recent report on Nuclear, Biological Chemical and Radiological had said that 400 security personnel had been trained to handle any man made emergencies in and around the Parliament House. The National Industrial Security Academy in Hyderabad is a regional-level institution that conducts training for the rapid response units, especially on NBC emergencies. Since 2002, the National Civil Defence College at Nagpur

40 March 2014

Is India Ready.indd 40

has been recognised as a nodal training institute for NBC emergencies training by the ministry of home affairs. Both the DRDO and the NDMA, with major funding from the ministry of home affairs, will soon be building a multipurpose NBC institute in Nagpur to engage in research, development and training for the military and to support the security forces, as well as to meet civilian needs. The institute is expected to be operational by 2016. Dr Dabhole says that India is using its growing biotech infrastructure to support biodefense R&D, including the development of countermeasures – civilian and military – ranging from protective equipment to pharmaceuticals to vaccines. India's biodefense programme dates back to at least 1973. The DRDO is spearheading biodefense R&D for civilian and military purposes. It has been working on detection, diagnosis and decontamination measures, such as unmanned ground vehicles and robots that could be sent into contaminated zones. Medical management during biological and chemical attacks also is being investigated. Other methods of defense currently under development include inflatable structures that can serve as shelter during a biological attack. In July 2010, India's Cabinet Committee on Security approved a project under which the DRDO has been tasked with developing swift detection systems in case of an NBC Pharma Bio World

18-03-2014 18:48:00

news features (nuclear, biological, chemical) attack on the country's vital installations and cities or leakage in any of the installations dealing with these materials. The DRDO, which caters primarily to the Armed Forces, unveiled plans in 2010 to upgrade its existing biotech products and to customise them for civilian use. It has budgeted more than USD 60 million for upgrading biotech products for both the armed forces and civilians, including intensive-care units, ready-to-eat food products, and clothing that can be worn during NBC warfare. The DRDE in Gwalior, particularly its microbiology and virology divisions, is the primary military biodefense establishment. It is involved in studies of toxicology and biochemical pharmacology and in the development of antibodies for several bacterial and viral agents. It is actively engaged in research on biological agents and toxins and has developed diagnostic kits for certain biological agents. Scientists at the establishment also are researching new methodologies to defend the country against a range of potentially lethal agents categorised as Class A, B and C pathogens, nanotechnology-based sensors, unmanned robot-operated aerial and ground vehicles fitted with NBC detection sensors, laser-based detection for chemical clouds, and selfcontained NBC shelters and hospitals to handle NBC victims. “The Indian Army has already inducted an NBC reconnaissance vehicle and ordered eight such vehicles to counter future threats posed by hostile state and non-state actors. Work at the facility focuses on countering bioweaponsrelated disease threats, such as anthrax, botulism, brucellosis, cholera, plague, smallpox and viral haemorrhage fevers. The DRDE has advanced diagnostic facilities for bacterial, viral and rickettsial diseases,” explaines Dr Dabhole. Pharma Bio World

Is India Ready.indd 41

Biological Attack: Responsibilities

Challenges

and

Dr Dabhole feels that every section of the society has an important role in detection and prevention of biological attack. The technical community has the greatest and most urgent challenge to develop effective detectors, both on the battlefield and in biological agent detectors similar to metal detectors. This effort should be a top priority. There should also be technological exploration, in concert with the intelligence community, for means to detect clandestine biological production facilities. The state-ofthe-art must be pushed to find some means to detect a production facility with certainty, no matter the size. Both human intelligence and the national technical means must be greatly improved. The medical community should continue to work on biological warfare vaccinations that are broad-based, safe, and in sufficient quantities to inoculate those people most susceptible to biological warfare attacks. This daunting task will be even more challenging given the controversy about the vaccines administered during Desert Storm and their suspected connection with the Gulf War Syndrome. Doctors should also strive to improve the postattack treatment in terms of rapid diagnosis, effective medical treatment, and a responsive surge capability to administer to large numbers of biological warfare-exposed patients. The intelligence community must be strengthened and sensitised in its efforts to gather data on the biological warfare threat. More resources should be directed toward identifying biological warfare threats by human and national technical means. This is especially important to deter terrorism in the interim until human intelligence and national technical means can provide more definitive answers about who are the haves and have nots. Does India Possess Biological Weapons? India is known to possess nuclear weapons, and in the past possessed chemical weapons.

Though India has not made any official statements about the size of its nuclear arsenal, recent estimates suggest that India has between 90 and 110 nuclear weapons, consistent with earlier estimates that it had produced enough weapons-grade plutonium for up to 75–110 nuclear weapons. As of 1999, India was estimated to have 4200 kg of separated reactor-grade plutonium from its power reactors, which is equivalent to roughly 1000 nuclear weapons. India is not a signatory to the 1968 Nuclear Non-Proliferation Treaty (NPT), which India argues entrenches the status quo of the existing nuclear weapons states whilst preventing general nuclear disarmament. India has signed and ratified both the Biological Weapons Convention and the Chemical Weapons Convention. “India has a well-developed biotechnology infrastructure that includes numerous pharmaceutical production facilities biocontainment laboratories (including BSL-3 and BSL-4) for working with lethal pathogens. It also has highly qualified scientists with expertise in infectious diseases. Some of India's facilities are being used to support research and development for BW defence purposes. India has ratified the BWC and pledges to abide by its obligations. There is no clear evidence, circumstantial or otherwise, that directly points toward an offensive BW programme. New Delhi does possess the scientific capability and infrastructure to launch an offensive BW program, but has chosen not to do so. In terms of delivery, India also possesses the capability to produce aerosols and has numerous potential delivery systems ranging from crop dusters to sophisticated ballistic missiles,” says Dr Dabhole. No information exists in the public domain suggesting interest by the Indian government in delivery of biological agents by these or any other means. To reiterate the latter point, in October 2002, Indian President APJ Abdul Kalam asserted that "we [India] will not make biological weapons. It is cruel to human beings.” - Mahesh Kallayil March 2014 41

18-03-2014 18:48:30

pharma news Ranbaxy, Sun Pharma Call Back Drugs in US

grants to Lee’s Pharmaceutical the right to manufacture, develop and commercialise tafoxiparin for obstetrics and gynecological indications in China, Hong Kong, Macau and Taiwan.

Indian multinational pharmaceutical company, Ranbaxy Laboratories, has recalled more than 64,000 bottles of Atorvastatin calcium tablets - a generic version of cholesterol-lowering drug Lipitor - in the US after dosage mix-up was detected.

Pursuant to the terms of the agreement, Dilafor and Lee’s Pharmaceutical will jointly develop tafoxiparin for obstetrical and gynecological indications. The joint clinical development programme of tafoxiparin will initially be focused on reducing labor times for patients who do not start labor spontaneously and are induced into labor, an indication where both Dilafor and Lee’s Pharmaceutical see a major medical need for the product in terms of improving outcomes for both mother and baby.

According to US FDA website, the action was taken after a complaint by a pharmacist, who discovered a 20 mg tablet inside a sealed bottle of Atorvastatin 10 mg tablets. In the meantime, another Indian generic-drug maker Sun Pharmaceutical Industries Ltd initiated a voluntary recall of 2,528 bottles of metformin hydrochloride extended release tablets after a customer complained of the presence of some gabapentin tablets, a drug used to treat seizures, in a bottle, according to a posting on the US FDA website.

QIAGEN Introduces careHPVTM Test in India QIAGEN NV announced the commercial launch in India of its careHPVTM Test, the only molecular diagnostic for high-risk human papillomavirus (HPV) designed to screen women in settings with limited healthcare infrastructure, such as areas lacking electricity, water or laboratories. HPV is the primary cause of cervical cancer in women, so screening for the viral infection is a powerful strategy for prevention and early treatment of the deadly cancer. The careHPV Test was launched commercially in China in 2013 and has been used in several other countries, including as part of QIAGEN’s corporate social responsibility effort, QIAGENcares. The careHPV Test for low-resource settings is highly complementary with QIAGEN’s digene HC2 HPV Test, the world’s most validated and sensitive diagnostic test for detection of high-risk HPV. The digene HC2 HPV Test is recognised as the “gold standard” in HPV screening and is widely used in developed countries and in large cities in emerging markets. About 72,000 women in India die of cervical cancer each year, more than one-fourth of the world’s 270,000 annual deaths. In India, cervical cancer accounts for about 20 per cent of all cancerrelated deaths in women and is the number one cause of death in middle-aged Indian women.

Dilafor, Lee’s Pharma to Develop Tafoxiparin Dilafor AB, part of Karolinska Development’s portfolio of companies, and Lee’s Pharmaceutical Holdings Ltd, have entered into a license agreement. According to the agreement, Dilafor 42 March 2014

Pharma News_Edited.indd 42

Venus Remedies to Foray into Myanmar Market Venus Remedies Ltd, a research-based global pharmaceutical company, is all set to stamp its footprint in Southeast Asia with marketing authorisation for its flagship research product, Elores, from Myanmar. The company plans to launch the drug in Myanmar by April. Venus Remedies has already received patents for Elores from 46 countries. The registration procedure of this product is in advanced stages in 13 European Union member-nations and 15 other countries, including South Korea, South Africa and Saudi Arabia. The company has signed deals with South Korean pharmaceutical company Goodwill Pharma and South African firm Austell Laboratories for the exclusive marketing of Elores. Ever since it was launched in India in January 2013, Elores has been receiving a tremendous response from the medical fraternity across the country. Elores is known for its efficacy against serious multidrug-resistant hospital-acquired infections involving metallobeta-lactamase and carbapenem-resistant strains of bacteria such as E coli, K pneumoniae, P aeruginosa and A baumanni.

AstraZeneca’s MYALEPT Gets US FDA Approval AstraZeneca has announced the US Food and Drug Administration (FDA) approved orphan drug MYALEPT (metreleptin for injection), which is indicated as an adjunct to diet as replacement therapy for the treatment of complications of leptin deficiency in patients with congenital or acquired generalised lipodystrophy. MYALEPT, a recombinant analogue (laboratory-created form) of human leptin, is the first and only treatment approved by the FDA for these patients. AstraZeneca is working to complete the transfer of the Biologics License Application (BLA) for MYALEPT from Bristol-Myers Squibb Company to AstraZeneca as part of the acquisition of the diabetes alliance assets, including MYALEPT and Amylin Pharmaceuticals, which was completed on 1 February 2014. Pharma Bio World

19-03-2014 10:00:33

pharma news DaVita to Provide Clinical Management TeraDiscoveries, Egenix to Jointly Design Cancer/Autism Drugs Services to Aethlon Aethlon Medical Inc, the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, has reached an agreement in principle with DaVita Clinical Research (DCR) to provide clinical management services that will support forthcoming studies of the Aethlon Hemopurifier. The Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumorsecreted exosomes that suppress the immune system of cancer patients. DCR is a specialty contract research organisation (CRO) with experience in conducting more than 300 early phase clinical trials. As a subsidiary of DaVita Healthcare Partners, DCR has access to one third of the total US end-stage renal disease (ESRD) patient population and maintains a network that exceeds 150 investigative physicians practices at more than 250 clinical sites.

EMA to Review Cubist’s Tedizolid MAA Cubist Pharmaceuticals, Inc has announced that the European Medicines Agency (EMA) has accepted for review the Company’s Marketing Authorization Application (MAA) for its investigational antibiotic tedizolid phosphate. Cubist is seeking approval of tedizolid for the treatment of complicated skin and soft tissue infections (cSSTI), with a decision from the European Commission (EC) expected during the first half of 2015. Tedizolid is a once daily oxazolidinone being developed for both intravenous (IV) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The MAA submission is based on positive data from two global Phase 3 clinical studies of tedizolid, which met the primary and secondary endpoints defined by the EMA and US Food and Drug Administration (FDA).

Salix, RedHill Ink License Deal for RHB106 Encapsulated Bowel Preparation Salix Pharmaceuticals Ltd and RedHill Biopharma Ltd have entered into an exclusive agreement by which Salix has licensed the worldwide exclusive rights to RedHill’s RHB-106 encapsulated formulation for bowel preparation and rights to other purgative developments. Financial terms of the transaction include an upfront payment of USD 7 million and USD 5 million in subsequent milestone payments to RedHill. Salix also has agreed to pay RedHill tiered royalties on net sales, ranging from low single-digit up to low double-digits. Under the worldwide license agreement, the parties also agreed on potential strategic collaboration with regard to certain other Salix products in specific territories. Pharma Bio World

Pharma News_Edited.indd 43

TeraDiscoveries, Inc has announced a strategic partnership with Egenix, Inc, a privately held New York based biotechnology firm. The two companies are working together to design new drugs that are effective against cancer and autism. TeraDiscoveries will use its Inverse Design software platform to design new drug molecules to effectively help Egenix accelerate its drug discovery and development process. Egenix is providing funding and target data that TeraDiscoveries will apply to identify and optimise inhibitors for certain cancer indications and autism. Egenix will develop the drugs through Phase 2 while TeraDiscoveries retains a minority stake in the two drugs. Inverse Design runs computational models to quickly scan a vast chemical space to find the strongest inhibitors of a specific biological target, ones that also have good druggable properties and are predicted to have low toxic side effects. Inverse Design also has filters for many important drug properties including toxic side-effect risk assessment, off-target effects assessment, synthesizability, solubility, freedom to operate assessment. Specialised filtering can assess if a molecule crosses the bloodbrain barrier.

Bayer to Buy China-based Dihon Pharmaceutical Group Bayer plans to acquire 100 per cent of the shares of Dihon Pharmaceutical Group Co, Ltd, Kunming Yunnan, China, a privately held pharmaceutical company specialising primarily in over-the-counter (OTC) and herbal traditional Chinese medicine (TCM) products. Dihon is a leading player in China’s OTC industry with Dr Marijn Dekkers products such as Kang Wang for the treatment CEO, Bayer of dandruff and other scalp disorders and Pi Kang Wang, an antifungal cream, as well as TCM product Dan E Fu Kang for the treatment of various women’s health indications. Financial details have not been disclosed. The transaction is subject to fulfillment of certain conditions, including merger control clearance, and is expected to close in the second half of 2014. “We aim to strengthen our Life Sciences portfolio with strategic bolt-on acquisitions globally. We are very pleased to have identified a consumer health care company in China with such a strong track record of success built by its dedicated employee base,” said Dr Marijn Dekkers, CEO of Bayer AG. “This acquisition moves us into a leading position amongst multinationals in the OTC industry in China. It also brings a portfolio of well-known consumer brands, which will allow us to provide consumers with an even broader range of self-care options.” March 2014 43

19-03-2014 10:01:01

pharma news Anika’s MONOVISC Gets US FDA Pernix, Osmotica Ink Pact to Market Khedezla ER Tablets Marketing Approval Anika Therapeutics, Inc has received marketing approval for MONOVISC from the US Food and Drug Administration (FDA). MONOVISC is a single injection supplement to synovial fluid of the osteoarthritic joint, used to treat pain and improve joint mobility in patients suffering from osteoarthritis (OA) of the knee. MONOVISC is the first FDA approved single injection product with HA from a non-animal source. It is comprised of a sterile, clear, biocompatible, resorbable, viscoelastic fluid composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate buffered saline. MONOVISC will be marketed in the US by DePuy Synthes, Mitek Sports Medicine (Mitek), a leading orthopedic sports medicine company. Under the license agreement with Mitek, Anika will receive a milestone payment of USD 5 million upon first commercial sale of MONOVISC in the market. The agreement also calls for potential additional payments contingent on achieving certain performance and sales threshold milestones, in addition to product transfer and royalty fees. Anika has marketed MONOVISC internationally since 2008. The product is currently sold in a variety of territories, including Canada, the UK and several countries in the Middle East, Europe and Asia.

Perrigo Acquires OTC Products from Aspen Perrigo Company plc has acquired a basket of value-brand OTC products sold in Australia and New Zealand from Aspen Global Inc for USD 51 million in cash. The products are primarily sold through the mass retail channel and include the Herron range of analgesics, vitamins and supplements. This basket of products is expected to generate at least USD 20 million in annual revenue. From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland, has grown to become a leading global healthcare supplier. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri. The Company is the world’s largest manufacturer of OTC healthcare products for the store brand market and an industry leader in pharmaceutical technologies. Perrigo’s mission is to offer uncompromised “Quality Affordable Healthcare Products,” and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as more than 40 other key markets worldwide, including Canada, China and Latin America. 44 March 2014

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Pernix Therapeutics Holdings Inc, a specialty pharmaceutical company, has signed an agreement with Osmotica Pharmaceuticals Corp to market and sell KHEDEZLA (desvenlafaxine) Extended-Release (ER) Tablets, 50 mg and 100 mg. The sales and marketing of KHEDEZLA will be supported by Pernix’s team of approximately Doug Drysdale 90 sales professionals, promoting the product Chairman and CEO Pernix to high desvenlafaxine prescribing physicians. The New Drug Application (NDA) for KHEDEZLA Tablets was approved by the US Food and Drug Administration pursuant to section 505(b) (2) of the Federal Food, Drug, and Cosmetic Act in July 2013. KHEDEZLA is indicated for the treatment of major depressive disorder (MDD). “We are pleased to add KHEDEZLA to the Pernix product portfolio,” said Doug Drysdale, Chairman and CEO of Pernix. “KHEDEZLA provides Pernix with an opportunity to leverage its greatest asset – our team of 90 professional sales men and women and represents the first step in our transformation to specialist promotion. KHEDEZLA has excellent promotional synergy with our sleep maintenance product, SILENOR. We believe that the ability to promote SILENOR and KHEDEZLA side by side provides a valuable product offering to Pernix’s target physicians.” The KHEDEZLA NDA included comparative bioequivalence testing against Pfizer’s PRISTIQ (desvenlafaxine) Extended-Release Tablets. According to IMS Health data, annual US sales of PRISTIQ are approximately USD 614 million.

Isis Gets USD 1 Mln from GSK for Advancing ISIS-TTR Rx Study Isis Pharmaceuticals, Inc has earned a USD 1 million milestone payment from GlaxoSmithKline (GSK) related to the initiation of an open-label extension study of ISIS-TTRRx, which is being offered to those patients with familial amyloid polyneuropathy (FAP) who have completed dosing in the Phase 2/3 study of ISIS-TTRRx. ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterised by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has earned USD 25 million in upfront and milestone payments for advancing ISIS-TTRRx. This USD 1 million milestone payment is the third of the USD 50 million in milestone payments Isis is eligible to earn as the Phase 2/3 study progresses. In addition, if GSK elects to exercise its option to exclusively license the ISIS-TTRRx programme, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx. Pharma Bio World

19-03-2014 10:01:01

pharma news Cumberland Acquires Vaprisol from Astellas Pharma

provides Eisai with an option to jointly develop and commercialise two of Biogen Idec’s candidates for AD, the anti-amyloid beta (Aβ) antibody BIIB037 and an anti-tau monoclonal antibody.

Cumberland Pharmaceuticals Inc announced the acquisition of Vaprisol from Astellas Pharma US, Inc.

The collaboration initially will be centered on the co-development and co-commercialisation of Eisai’s two candidates: E2609, a β-site amyloid precursor protein cleaving enzyme (BACE) inhibitor, and BAN2401, an anti-Aβ antibody. These candidates have the potential to reduce Aβ plaques that form in the brains of patients with AD and to stop the formation of new plaques, potentially improving symptoms and suppressing disease progression.

Vaprisol is a patented, prescription brand indicated to raise serum sodium levels in hospitalised patients with hyponatremia. The product was developed and registered by Astellas and was commercially launched in 2006. It is one of two branded prescription products indicated for the treatment of hyponatremia. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. Under the terms of the agreement, Cumberland will assume full responsibility for the product including its marketing, distribution and manufacture. Cumberland will promote Vaprisol across the United States through its hospital sales force, which also features its Caldolor and Acetadote brands.

Sagent Recalls Two Lots of Zoledronic Acid Injection, 5mg/100mL Premix Bag Sagent Pharmaceuticals, Inc has announced the voluntary nationwide recall of two lots of Zoledronic Acid Injection, 5mg/100mL premix bag (NDC number 25021-830-82) distributed by Sagent. Sagent has initiated this voluntary recall of Zoledronic Acid Injection, 5mg/100mL to the user level due to the discovery of four leaking premix bags detected during an investigation conducted in response to a product complaint. The subject bags were not administered to patients as the leakage was readily apparent. A non-integral premix bag can result in a lack of sterility assurance. Sagent is not aware of any adverse patient events resulting from the use of this product and is continuing its investigation of the situation. The lots being recalled are numbers 30076 and 30077 which were distributed to hospitals, wholesalers and distributors nationwide from October 9, 2013 through February 18, 2014. Zoledronic Acid Injection, 5mg/100mL is a bisphosphonate indicated for the treatment of Paget’s disease of bone in men and women and is supplied in a premix bag.

Eisai, Biogen Join Hands to Develop Alzheimer’s Disease Treatments Eisai Co Ltd and Biogen Idec have entered into a collaboration to develop and commercialise two of Eisai’s clinical candidates for Alzheimer’s disease (AD), E2609 and BAN2401. The agreement also Pharma Bio World

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Eisai will serve as the operational and regulatory lead in the codevelopment of E2609 and BAN2401 and will pursue marketing authorisations for both compounds worldwide. In major markets, such as the United States and the European Union, Eisai and Biogen Idec will also co-promote the products following marketing approval. Both companies will share overall costs, including research and development expenses, with Eisai booking all sales for E2609 and BAN2401 and with profits to be split between the companies. Biogen Idec will provide Eisai with an upfront payment and a fixed amount of development, approval and commercial milestone payments. The agreement also includes options for Eisai to receive an additional one-time payment from Biogen Idec related to joint development and commercialisation activities in Japan.

Simulations Plus, US FDA Ink Research Collaboration Agreement Simulations Plus Inc, a leading provider of software for pharmaceutical discovery and development, has signed a five-year research collaboration agreement (RCA) with the US Food and Drug Administration (FDA) to work together to determine the value of mechanistic absorption modeling (MAM) in developing predictive and robust in vitro-in vivo correlations (IVIVCs). The collaboration will examine how the use of MAM can provide additional insight and greater accuracy with regards to prediction of complex drug absorption characteristics. The ultimate goal is to facilitate drug and generic product development by decreasing the regulatory burden through adequate modeling approaches. Under the agreement, Simulations Plus will provide licenses for the Company’s GastroPlus simulation software to model in vivo data representative of challenging absorption characteristics to the FDA’s Office of Testing and Research located in the Center for Drug Evaluation and Research Office of Pharmaceutical Science. During the first year, the Company will provide training to FDA investigators regarding the underlying mathematical models. During the course of the collaboration, ideas and recommendations will be exchanged between the FDA and the Company that aim to improve MAM. The collaborators plan to make results from this research available to the public. March 2014 45

19-03-2014 10:01:01

pharma news Novartis’ Xolair Gets EU Nod

David Epstein Division Head Novartis Pharmaceuticals

Novartis announced that the European Commission (EC) has approved the use of Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. The approved dose is 300 mg by subcutaneous injection every four weeks.

“The EU approval of Xolairin CSU is truly exciting for patients with this chronic and debilitating skin disease,” said David Epstein, Division Head of Novartis Pharmaceuticals. “With this new therapeutic option from our specialty dermatology portfolio, our aim is to help ensure that the up to 50 per cent of patients who suffer from CSU and don’t respond to approved doses of antihistamines have access to Xolairas quickly as possible in the EU.” At any given time, the prevalence of chronic urticaria (CU) is up to 1 per cent of the world’s population, and up to two thirds of these patients have CSU. CSU is also known as chronic idiopathic urticaria (CIU) in the US, and is a severe and distressing skin condition characterised by red, swollen, itchy and sometimes painful hives or wheals on the skin that spontaneously present and reoccur for more than six weeks. Up to 40 per cent of CSU patients also experience angioedema, a swelling in the deep layers of the skin

Celerion Expands to South Korea Celerion has announced the expansion of clinical operations to South Korea. Through partnership with Seoul National University Hospital (SNUH), the new Asian office is located within the SNUH Clinical Trials Centre. This enables Celerion and their clients’ access to the 80-bed clinical research unit, particularly geared toward clinical pharmacology, oncology, and pediatrics, as well as the highly trained staff at this centre. The new Asian office will be overseen by John Horkulak, Executive Director, Eurasian Site Operations. Horkulak brings over 20 years of experience in managing clinical pharmacology studies in patient populations to this role. The focus of the SNUH Clinical Trials Centre is translational medicine and aligns with Celerion’s strategic vision to provide effective global services that support growing interest in complex early clinical studies, often involving patients. In addition, Celerion has built relationships and audited three other clinical trial centres in South Korea to support the need for multi-site early clinical studies in patients often requiring confinement. 46 March 2014

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Endo’s AVEED Injection Gets US FDA Approval Endo International plc’s operating company Endo Pharmaceuticals Inc received US FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March. The approval of AVEED is based on data from an 84-week Phase 3 trial of hypogonadal men in the US Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL. In the Phase 3 study, AVEED increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state (between weeks 14-24). AVEED is approved with a Risk Evaluation and Mitigation System (REMS) requiring prescriber education and certification as well as restricted product distribution.

Healios, Dainippon Establish JV, SighRegen Healios KK and Dainippon Sumitomo Pharma Co, Ltd have established a joint venture company, SighRegen KK, following the terms of the joint venture agreement the two companies signed on December 2, 2013. On the same date, they also signed the joint development agreement on the terms of the joint development in Japan of iPS cell-derived retinal pigment epithelial cells for the treatment of age-related macular degeneration and other eye diseases. The joint venture company will be engaged in the manufacture and sales promotion of the iPS cell-derived RPE cell products commercialised in the future through the joint development. According to the joint venture agreement, the JV company, SighRegen (SighRegen is a term coined from “(eye)sight” and “regeneration”) will be located at 5-2 Minatojima Minamimachi 5-chome, Chuo-ku, Kobe, Hyogo.

Pfizer to Appeal Court Decision on Celebrex Reissue Patent Pfizer Inc confirmed that the United States District Court for the Eastern District of Virginia granted summary judgment invalidating the reissue patent (US Patent No RE44,048), covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex. Pfizer disagrees with the ruling and will pursue all available remedies, including an immediate appeal of the court’s decision. Pharma Bio World

19-03-2014 10:01:01

press release Jubilant Biosys Extends Drug Discovery Global CF Market Value to Grow USD 4.5 Alliance with Janssen Pharmaceutical Bln by 2019 Jubilant Biosys, a Bengaluru based subsidiary of Jubilant Life Sciences, has expanded its drug discovery alliance with Janssen Pharmaceutica NV, Beerse, Belgium. The alliance was forged initially in the year 2011 and aims to deliver preclinical candidates to Janssen. The new agreement into multiple therapeutic areas has been expanded owing to Jubilant’s diversified skill sets in various therapeutic areas. Most of the research will be undertaken at Jubilant Biosys, India and some parts at Jubilant Discovery Centre, USA. In another development, Jubilant Life Sciences Ltd, an integrated Pharmaceuticals and Life Sciences Company announced has received a communication from the US Food and Drug Administration (FDA), classifying its pharmaceutical manufacturing facility at Montreal, Canada as ‘Acceptable’. This resolves all issues raised by the FDA on the facility in February 2013 and subsequent communications. The development follows completionof FDA’s review of the Company’s responses post the February letter and the subsequent re-inspection conducted at Jubilant’s Montreal facility in September, 2013. This development successfully resolves the FDA issues at Montreal facility.

The global Cystic Fibrosis (CF) market value in the seven major countries (7MM: the US, Canada, France, Germany, Italy, Spain and the UK) will jump from USD 1.2 billion in 2013 to just under USD 4.5 billion by 2019, at a massive Compound Annual Growth Rate (CAGR) of 30.4 per cent, says a new report from business intelligence provider GBI Research. According to the report, the five European Union (5EU) countries will show the most growth in the CF market, with their total value climbing from USD 568 million in 2013 to just over USD 2.2 billion by 2019, at a CAGR of 32.3 per cent. The UK and Spain will have the region’s highest CAGRs of 34.4 and 33.9 per cent, respectively. The 5EU countries will be followed by the US, with its CF market value expected to increase from USD 636 million in 2013 to USD 2.2 billion by 2019, at a CAGR of 28.6 per cent.

IPC-IMA TNSB Pharmacovigilance CME Held at Chennai

Cirrius App Now Available on Windows Devices Pharmaceutical companies can now empower medical representatives with information on their fingertips before, during and after a doctor’s call with the Cirrius Platform on Windows 8. This application enables the representatives to detail medical content inside the clinic and report each call by utilising the time spent waiting for a meeting. Managers can access real-time data to take informed tactical and strategic decisions. The Cirrius Platform offers a unique combination of SFA (Sales Force Automation), CRM (Customer Relationship Management) and CLM (Closed Loop Marketing) all bundled into one seamlessly integrated mobility solution. The platform caters to the needs of the medical representative comprehensively with feature rich functionality that includes daily reports, e-detailing, tour planning, inventory, order management, expense tracking etc. all on their devices anytime anywhere. Rich analytics on the platform’s web portal as well as devices allows managers to monitor field activities and selfservice administration consoles enable changes to field users and structure. The platform easily integrates with other systems like ERP, CRM, HRMS etc to exchange information across the enterprise. The Cirrius platform forms an integral part of the Enterprise Information ecosystem. Pharma Bio World

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Indian Pharmacopoeia Commission, the National Coordination Centre for the Pharmacovigilance Programme of India organised a Pharmacovigilance CME for Practising Doctors, in technical collaboration with Indian Medical Association Tamil Nadu State Branch, at Chennai on 22-Feb-2014. Dr J Vijay Venkatraman, Managing Director & CEO of Oviya MedSafe Pvt. Ltd. and Hon. Secretary Elect, Indian Medical Association – Coimbatore Branch, who was the coordinator of the CME programme welcomed the gathering and thanked the Indian Pharmacopoeia Commission and the office bearers of Indian Medical Association Tamil Nadu State Branch for making the event a reality. He mentioned that Indian Medical Association Tamil Nadu State Branch was the first professional association of clinicians with whom Indian Pharmacopoeia Commission had collaborated while organising the nationwide CMEs over the past few years. March 2014 47

20-03-2014 13:18:05

press release ÄKTA Awarded as ‘Best New Separations Canara Bank, Biocon and OTTET to Product of 2013’ Boost Healthcare Delivery in Odisha Ä K TA s t a r t , a c o m p a c t , a ff o r d a b l e a n d e a s y - t o - u s e preparative chromatography system for laboratory-scale protein purification by GE Healthcare Life Sciences, a Akta team business unit of GE Healthcare, has been awarded the prestigious Scientists’ Choice Award. Ä K TA s t a r t w a s a n n o u n c e d a s t h e w i n n e r o f ‘ B e s t N e w Separations Product of 2013’ award during a ceremony held at the Pittcon 2014 Conference and Expo in Chicago, Illinois, USA. T h e S c i e n t i s t s ’ C h o i c e Aw a r d i s c o n d u c t e d a n n u a l l y b y SelectScience, an independent, expert-led scientific review resource for the worldwide scientific community. The awards enable scientists around the world to voice their opinions on the best laboratory products. This year’s Scientists’ Choice Awards attracted over 2,500 nominations and votes from scientists around the world.

FDA, EMA to Discuss Pharmacovigilance at DIA’s Annual Meeting The Food and Drug Administration (FDA) and European Medicines Agency (EMA) will discuss common objectives and challenges in pharmacovigilance and clinical safety at DIA’s Annual Meeting from June 15 to 19 in San Diego. The June 17 session, “FDA-EMA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges,” will focus on joint efforts in drug-specific evaluation, drug development, effective implementation of new pharmacovigilance (medicine safety) tools and addressing common challenges. The session, to be chaired by Peter Richard Arlett, head of pharmacovigilance at EMA, is one of 35 educational sessions at the Annual Meeting focusing on pharmacovigilance and clinical safety. “Ensuring the safety of medical innovations is a top priority for professionals involved in medical product development,” said DIA Global Chief Executive Barbara Lopez Kunz. “We are bringing the premier voices in industry and regulatory agencies to work closely on this issue in addition to encouraging a stronger patient voice in our education.” The two agencies jointly announced on Feb. 21 the creation of a new “cluster” for a more systematic and focused exchange of information on the safety of medicines. Clusters are regular meetings among the FDA, EMA and other world drug regulatory agencies on specific topics identified as requiring intensified sharing of information and collaboration. 48 March 2014

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Canara Bank has lent support to Biocon Foundation and OTTET (Orissa Trust of Technical Education) for a unique public private partnership (PPP) with the Odisha government to deliver a novel ehealthcare programme for the underprivileged and rural communities in the state. OTTET has been actively engaged in an e-Health programme with the Government of Odisha through PPP to provide access to quality healthcare for 51,000 villages in Odisha. Biocon Foundation has joined hands with OTTET to augment and implement a unique mega-ICT based e-Health project in the state. The partners through this collaboration will strive to deliver evidence-based health care to effectively deal with primary health and chronic conditions in communities that have poor access to quality healthcare.

Boom in Smart Pills will Reach a New Peak by 2018-2020 The increasing need for convenient diagnostic and accurate therapeutic tools is driving innovation in smart pills. While certain smart pill applications, such as imaging and sensing, have been successfully commercialised, others like drug delivery and surgery are yet to be proven clinically. There is also commercialisation preference and focus on wireless capsule endoscopes and ingestible sensors for internal signs monitoring. New analysis from Frost & Sullivan, Innovations in Smart Pills, finds a clear trend towards minimally invasive and remote controlled devices for diagnosis and therapy. Smart pills are widely used for gastrointestinal imaging too, replacing invasive endoscopes. Advancements in enabling technologies, such as wireless communications, remote patient monitoring, and miniaturisation, will widen smart pill applications.

Japan’s Schizophrenia Treatment Market Value to Double by 2022 Japan’s schizophrenia treatment market value will undergo significant growth over the coming decade, with revenues doubling from USD 0.7 billion in 2012 to USD 1.4 billion by 2022, says a new report from research and consulting firm GlobalData.The company’s report states that out of the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan), the latter will experience the greatest expansion over the forecast period. It will be followed by the UK and French markets, which are expected to achieve CAGRs of 5.58 and 4.65 per cent, respectively.A key driver behind Japan’s schizophrenia market revenue growth will be the doubling of available therapy options between 2012 and 2022, which will offer patients greater autonomy, according to GlobalData. Pharma Bio World

20-03-2014 13:18:18

biotech news Plasticell, JCR Pharmaceuticals Ink Andromeda Buys DiaPep277 from Teva Collaboration Agreement Andromeda Biotech Ltd has entered into an agreement with

Dennis Saw, Chief Executive, Plasticell

Plasticell, the biotechnology company specialising in stem cell differentiation, has signed a collaboration agreement with JCR Pharmaceuticals Co, Ltd of Ashiya, Hyogo Pref, Japan, to discover custom stem cell culture media using its award-winning combinatorial stem cell technology, CombiCult.

Teva Pharmaceutical Industries Ltd for the acquisition of Teva’s rights for Andromeda’s drug, DiaPep277, for the treatment of Type 1 Diabetes. According to the Agreement, Teva shall transfer its rights in DiaPep277 and all of its shares in Andromeda to Andromeda, for total consideration of approximately USD 72 million, payable in installments through future payments based on Andromeda’s revenues or on proceeds payable to its shareholders.

Under the terms of the agreement, Plasticell will use its stem cell expertise to work with JCR scientists, deploying CombiCult to discover novel GMP-ready protocols for therapeutic applications. Financial terms of the agreement were not disclosed.

Andromeda will ensure that the development programme of DiaPep277, currently in a confirmatory phase 3 study, will continue according to plan without delays to gain regulatory approval.

“Plasticell’s core capability to provide customers with optimised serum- and xeno-free GMP-grade stem cell differentiation or expansion protocols, which exclude patented factors and contain small molecule substitutes, together with the knowledge we have accumulated from a decade of differentiating all types of stem cells into a multitude of different cell types, has great potential to enhance the competitiveness of the Japanese stem cell effort,“ remarked Dennis Saw, Chief Executive of Plasticell. “The attractiveness of our technology is evidenced by this timely collaboration with JCR, the leading Japanese pharma in the stem cell field.”

Verastem Buys VS-4718 Rights from Poniard Pharma

ThromboGenics to Explore Commercial Potential of Jetrea in US Market

VS-4718 is an oral compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research by Robert Weinberg, PhD, scientific cofounder and chair of Verastem’sScientific Advisory Board, Verastem and others have demonstrated that the FAK pathway is critical for the growth and survival of cancer stem cells.

ThromboGenics, an integrated biopharmaceutical company focused on developing and commercialising innovative ophthalmic medicines for the back of the eye, has announced that the Board has decided to explore strategic options for the Company. This decision is intended to increase the Company’s ability to realise the significant commercial potential of Jetrea in the US, and to fully capitalise on the Company’s proven product development capabilities. The Board has retained Morgan Stanley to help with the strategic review process.ThromboGenics successfully developed Jetrea, the first and only pharmacological treatment indicated for symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) in the US and Europe respectively. Symptomatic VMA/ VMT is a progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness. Jetrea offers an earlier and easy to administer treatment option, which avoids patients having to experience deterioration in their disease state to a point where a vitrectomy is the only solution. Pharma Bio World

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Verastem, Inc, focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, has acquired the license to VS-4718 held originally by Poniard Pharmaceuticals. The previous and future developmental, regulatory and commercial royalty milestones and payments associated with the development and potential future sales of VS-4718 due to Poniard Pharmaceuticals are now owned by Verastem. Verastem retains a license to VS-4718 from TheScripps Research Institute.

Andromeda Acquires DiaPep277 Rights Andromeda Biotech Ltd has entered into an agreement with Teva Pharmaceutical Industries Ltd for the acquisition of Teva’s rights for Andromeda’s drug, DiaPep277, for the treatment of Type 1 Diabetes. According to the Agreement, Teva shall transfer its rights in DiaPep277 and all of its shares in Andromeda to Andromeda, for total consideration of approximately USD 72 million, payable in installments through future payments based on Andromeda’s revenues or on proceeds payable to its shareholders. Andromeda will ensure that the development programme of DiaPep277, currently in a confirmatory phase 3 study, will continue according to plan without delays to gain regulatory approval. March 2014 51

19-03-2014 09:57:28

biotech news UNICEF to Buy IPV from Sanofi Pasteur La Jolla Pharmaceutical, GW Sign for Polio Eradication Programme LJPC-501 Technology Deal Sanofi Pasteur, the vaccines division of Sanofi, has announced its further commitment to the international community’s efforts to complete polio eradication. UNICEF, the organisation that procures the vaccine to meet global needs, announced it will purchase significant quantities of Inactivated Polio Vaccine (IPV) from Sanofi Pasteur and make it available based on country needs and vaccination plans. To achieve the goal of polio eradication by 2018, the World Health Organization (WHO) recommends that by end 2015, all children receive routinely at least one dose of IPV in over 120 countries that solely use Oral Polio Vaccine. In order to support rapid and widespread adoption of IPV, Sanofi Pasteur - the world’s largest producer of IPV – and the Bill & Melinda Gates Foundation have developed a joint price support mechanism, including a financial contribution from both organisations. This mechanism allows Sanofi Pasteur to offer IPV at a price of EUR 0.75 per dose (approximately USD 1) to 73 of the world’s poorest countries. The GAVI Alliance, a global immunisation partnership, will make IPV available for inclusion in routine immunisation schedules in these countries. This announcement underscores Sanofi Pasteur’s commitment to offer unparalleled volumes of high-quality IPV across a broad range of countries and economic situations at differential prices in an unprecedented, global rollout.

Meditope’s mAb Drug Conjugates Gets US Patent

Stephanie Hsieh President and CEO Meditope

Meditope Biosciences, Inc, a biotechnology company developing novel antibodydrug conjugates using its proprietary monoclonal antibody (mAb) technology platform, has announced the issuance of its first patent, US Patent No. 8,658,774, entitled “Novel Meditopes and Related Meditope-Monoclonal Antibody Delivery Systems, Synthesis and Therapeutic Uses Thereof.”

“We view the issuance of this patent, about two years from initial filing, as validation of the novelty of our platform and an important step in our strategy to build and protect a strong and highly differentiated antibody technology,” said Stephanie Hsieh, Meditope’s president and chief executive officer. “Antibody drug conjugates are an area of significant opportunity in drug development and we look forward to leveraging our unique technology to address the industry’s needs.” 52 March 2014

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La Jolla Pharmaceutical Company, a biotechnology company developing therapeutics targeting significant unmet, life-threatening diseases, has signed an option agreement with the George Washington University (GW) that will add proprietary technology to the Company’s LJPC-501 programme. The option agreement with GW adds potential proprietary protection to La Jolla’s pipeline, which includes treatments for chronic kidney disease, hepatorenal syndrome, chronic iron overload, and rare diseases. “We look forward to working with the George Washington University to develop their technology related to LJPC-501,” said George Tidmarsh, President and CEO of La Jolla. “As we continue to expand our product portfolio, we remain committed to helping patients with severe diseases for which no treatment is available.”

Cobra Biologics, BioCancell to Jointly Manufacture Cancer Therapy Drug Cobra Biologics and targeted cancer therapy company BioCancell have announced an agreement to manufacture BioCancell’s BC821 cancer drug for clinical trials. BioCancell’s Phase I clinical trial for BC-821, scheduled to commence in 2015, is a continuity of the success of pre-clinical studies that examined the use of BC-821 as a treatment for several cancer indications such as Non-small-cell lung carcinoma, Ovarian cancer, Glioblastoma (brain tumour) and Liver metastasis. Cobra will provide GMP manufacture of BC-821 plasmid DNA, and fill and finish the product in accordance with aseptic manufacturing procedures before releasing it for clinical trials.

Synageva Gets US Patent for LAL Deficiency Treatment Synageva BioPharma Corp, a biopharmaceutical company developing therapeutic products for rare diseases, announced that the US Patent and Trademark Office issued US Patent No 8,663,631 covering methods of treating lysosomal acid lipase deficiency (LAL Deficiency). This patent provides protection until 2031, not including any patent term extension. The patent complements Synageva’s existing and planned global patent portfolio covering its LAL Deficiency programme, which includes intellectual property directed to composition of matter, methods of use, and manufacturing. Pharma Bio World

19-03-2014 09:59:30

biotech news US Patent for Vaccines Targeting HPV Biodel, Emergent Sign Manufacturing Induced Cancers and Influenza Deal for Glucagon Rescue Product Generex Biotechnology Corporation announced that its whollyowned subsidiary, Antigen Express, Inc has received Notices of Allowance from the United States Patent Office relating to applications for the use of therapeutic vaccines targeting human papilloma virus (HPV) caused cancers as well as to potentially pandemic strains of influenza virus. The Company has previously received allowances of broad claims surrounding the use of its Ii-Key hybrid technology platform. Both applications relate to vaccines designed using this platform, which was also used to design its AE37 vaccine that is currently in a late Phase II trial to prevent relapse in patients who have had breast cancer. The Company has previously published preclinical studies on lead compounds targeting HPV and conducted clinical trials of influenza targeted vaccines in healthy volunteers. While there are prophylactic vaccines on the market to prevent HPV infection, none are approved for use in the therapeutic setting to treat existing cancers caused by HPV. The added potency of Antigen Express vaccines derives from its ability to activate CD4+ T helper cells, which are critical in the generation of a novel immune response.

Biodel Inc has signed a long-term manufacturing agreement with Cangene bioPharma Inc doing business as Emergent BioSolutions (Emergent). Under the agreement, Emergent will fill and finish commercial quantities of the GEM device. Financial terms of the agreement have not been disclosed. The GEM device, to which Biodel holds exclusive rights for use with glucagon, is a customised version of Unilife’s dual-chamber auto-reconstitution syringe. GEM is being developed for use as a rescue treatment for severe hypoglycemia. GEM is an intuitive, easyto-use device designed to address and expand a market underserved by the currently available kits that are difficult to assemble and operate during an emergency. This fill and finish agreement, along with the previously-announced license and supply agreement for the GEM device with Unilife, and bulk glucagon supply agreement with Bachem, continue the Company’s preparation for the anticipated submission of a New Drug Application to the FDA in 2015 and subsequent commercial launch.

Pluristem Gets US FDA Nod for US FDA to Review Navidea’s sNDA to Manufacturing of PLX Cell Products Expand Lymphoseek Labeling Navidea Biopharmaceuticals Inc, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced that the US Food and Drug Administration(FDA) has accepted for review an additional Supplemental New Drug Application (sNDA) for the proposed expanded label for Lymphoseek (technetium 99m tilmanocept) Injection to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimisation capabilities. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target review date for the second Lymphoseek sNDA of October 16, 2014. The two Lymphoseek sNDAs now accepted are derived from a single, data-rich application submitted to FDA in December 2013. In assessing the application, FDA chose to separate the filing in two based on the proposed labeling extensions requested and the scope of information provided. This second sNDA application is aimed at expanding the Lymphoseek label to support more flexible utilisation practices for Lymphoseek in lymphatic mapping and lymphoscintigraphy imaging. The first sNDA, aimed at Lymphoseek’s use as a sentinel lymph node detection agent in patients with head and neck cancer, received FDA Fast Track designation and was accepted for Priority Review, as previously announced, with a PDUFA date target of June 16, 2014. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma. Pharma Bio World

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Zami Aberman, Chairman and CEO, Pluristem

Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapies, announced that the United States Food and Drug Administration (FDA) has reviewed Pluristem’s comparability studies of its PLacental eXpanded (PLX) cell products and granted approval for the Company to manufacture these products in its new commercial-scale cell manufacturing facility.

“We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies,” stated Zami Aberman, Chairman and CEO of Pluristem. “Knowing that the ‘Process is the Product’ in cell therapy, we have established our leadership position in the industry by focusing on our 3D commercial scale cell manufacturing processes. To be a successful company in the industry, we believe it is imperative to possess and control the manufacturing processes we have developed at Pluristem. We believe this FDA approval, combined with the approval given by the Paul-Ehrlich-Institute (PEI) of Germany announced on January 23, 2014, is an indication that these regulatory bodies see our proprietary 3D manufacturing process as a valid and sustainable commercial scale solution for potential cell therapies,” added Aberman. March 2014 53

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marketing initiative

COGNEX ADVANCES INDUSTRIAL ID WITH POWERFULNEWDATAMANSOFTWARE RELEASE Software update expands tuning and test mode options for DataMan fixed-mount ID readers

ognex Corporation (NASDAQ: CGNX) announced its DataMan® 5.2 software release with expanded tuning and scripting capability as well as a new test mode for its popular DataMan 300 and 503 series of barcode readers. The new software significantly increases read rates by decoding lower resolution 1-D codes and extending intelligent tuning capabilities to all symbologies, including Aztec, MaxiCode and PDF417. The software release includes the high-performance Hotbars™ algorithm, which handles both 1-D and PDF417 barcodes.

The DataMan 5.2 software release extends the easy-to-use 2-D intelligent tuning capability that was introduced by the popular DataMan 300 Series. This intelligent tuning capability decreased set up time while increasing read rates for Direct Part Mark (DPM) code reading applications. This software release extends that advanced capability to other symbologies, such as 1-D barcodes, MaxiCode and QR codes. These new tuning capabilities bring proven, industry-leading technology to code reading applications in consumer products, logistics, food, beverage and automotive. This new release also includes added capabilities to the scripting feature of the DataMan 300 for advanced logic and decision making in the reader, and 1-D barcode quality metrics for users to optimize their processes. “The DataMan 5.2 software release gives the DataMan 300and 503 readers a significant performance boost in both capability and ease of use,” said Carl Gerst, Vice President and Business Unit Manager, ID Products. “The field-proven intelligent tuning has been extended to all symbologies, making setup as simple as pushing a button. For more difficult applications, the enhanced scripting engine allows the logic and decision making to be done within the reader. This simplifies the PLC code integration into the factory network and saves our customers time and money.” The DataMan 5.2 software is available now for download. For more information about the DataMan 5.2 software and barcode readers, 54 March 2014

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visit http://www.cognex.com/code-readingtuning-technology. About Cognex Corporation Cognex Corporation designs, develops, manufactures and markets a range of products that incorporate sophisticated machine vision technology that gives them the ability to “see.” Cognex products include barcode readers, machine vision sensors and machine vision systems that are used in factories, warehouses and distribution centers around the world to guide, gauge, inspect, identify and assure the quality of items during the manufacturing and distribution process. Cognex is the world’s leader in the machine vision industry, having shipped more than 900,000 vision-based products, representing over$3.5 billion in

cumulative revenue, since the company’s founding in 1981. Headquartered in Natick, Massachusetts, USA, Cognex has regional offices and distributors located throughout North America, Japan, Europe, Asia and Latin America. For details visit Cognex online at http://www.cognex.com For further information, please contact: Sunil Vaggu Cognex Corporation Mobile: +91 9881466003 Email: vaggu.sunil@cognex.com OR Piya D Banerjee Mind Matters M: +91.9096699998 e-mail: mails@mindmatterscorp.com Pharma Bio World

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Horizontal Peeler Type Centrifuge Shiv Shakti Process Equipment Pvt Ltd offers horizontal peeler type centrifuge with full opening housing that gives complete access to the entire processing area which allows for ease of maintenance, inspection, cleaning and validation. Clean room installation is possible with separation of the processing area from the mechanical components which is achieved with a through the wall design. It has an inclined chute to facilitate cake discharge, which is easily accessed for cleaning and validation. Feeding of the slurry across the entire length of the basket ensures uniform cake thickness. It has various cake detection devices, numerous residual heel removal systems and is gas tight ready to receive an inerting system. There are several possibilities for control systems from completely manual to fully automatic with a local operator interface and the possibility of plant networking.

Best-fit Controller The Industry Sector of Siemens launched SIMATIC PCS 7 AS 410 SMART for small to mid-sized standard distributed control system (DCS) applications. This controller provides repeatability, meaning once a standard solution is designed, the same can be used for several similar applications as well. The AS 410 SMART can withstand harsh temperature conditions, vibration/shock and EMC requirements. It is also equipped with a conformal coating, which is in line with G3 Standards, thus making the controller highly robust.With a speed of 450 MHz, this multi-processor system is equipped with 48 MB memory and can be scaled up to 800 Process Objects. Simultaneous management and control of different process tasks at different cycle times is yet another advantage of this high speed controller. AS 410 SMART also provides ease of maintenance to customers as only one controller-spare part needs to be managed.

For more information, please contact:

Shiv Shakti Process Equipment Pvt Ltd Shiv Shakti, 407 Shivam Chambers Next to Sahara, S V Road, Goregaon (W), Mumbai 400 104 Tel: 022-26788480, 26798554, Fax: 91-022-26798284 E-mail: sales@shivshaktiequipments.com

Siemens Ltd. R&D Building, Kalwa Works Thane-Belapur Road, Airoli, Navi Mumbai 400 708 Tel: 022-33265707 E-mail: sourav.ghosh@siemens.com

New TouchTools PCR Wizard Aids Automated PCR Set-up Tecan has launched the TouchTools PCR Wizard, an easy-to-use Freedom EVOware add-on offering straightforward automation of PCR reaction set-up on Freedom EVO platforms. This new tool simplifies the set-up of applications including end-point, real-time and multiplex PCR, sequencing, genotyping and gene expression, as well as pathogen and mutagenesis detection helping to reduce training time and costs. The PCR Wizard’s effortless touchscreen operation and step-by-step instructions guide users through the set-up process, allowing sample information to be entered manually, imported from a file or identified by barcode scanning. Users can quickly and easily optimize 96- and 384-well PCR plate layouts to meet specific workflow needs using up to 96 master mixes and defining their own controls and dilution curves with just a single set-up required for multiple PCR plates per run. To avoid the risk of transcription errors, data can be exported in formats ready for the most popular real-time cyclers from Bio-Rad and Life Technologies, and optional integrated sample tracking further increases process security. For maximum flexibility, the PCR Wizard can be used in conjunction with the Freedom EVOware Normalization Wizard, providing simple, user-oriented solutions for the entire genomics workflow. For more information, please contact: Tecan Trading AG Seestrasse 103, CH-8708 Männedorf, Switzerland Tel: +41 (0)44 922 81 11 Fax: +41 (0)44 922 81 12 E-mail: info@tecan.com

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Agitators Fluidyme manufacture various types of direct and gear driven agitators, agitators with single and double mechanical seal and gland packing. Agitators are heavy-duty designed to process a wide range of fluids of varying viscosities and specific gravities in various processes like blending, dispersion, reactions in solution, flocculation, dissolution, solid suspension, gas dispersion, high viscosity mixing, heat transfer, crystallization/ precipitation in the industries, viz, pharma, chemicals, paint and coatings, screen ink, adhesives, resins, sealants, plastisols, concentrates, biotech, lubricant, coolant, paper, chemicals, dye, cosmetics, food, etc. Modular design of the agitator enables various mounting arrangements, ie, from open tank to closed tank. high efficiency impellers designed for specific process applications. eEfficient chemical duty totally enclosed (TEFC) or explosion-proof motors and air motors can be offered. Variable output speed by Variable Frequency Drive and inverter duty motors with power range from 0.06 to 50 HP and onwards. Fluidyme also manufacture agitators with reaction vessels, pressure vessels. dosing systems and pilot plants. high speed dispersers, emulsifiers with hydraulically or pneumatically operated lifting lowering arrangement, drum hoop mixer for mixing homogenizing viscous liquids, static mixers with standard and custom design, drum press-out for liquid filling applications. For more information, please contact: Fluidyme Process Flow Technologies E-2/4, Popular Prestige Off Highway Bridge Warje, Pune, Maharashtra 411 058 E-mail: fluidyme@vsnl.net.

High Shear Mixers with SLIM For demanding dissolution requirement, consider the solids/liquids injection manifold (SLIM) technology available on batch and inline Ross high shear mixers. It is a novel method of delivering solids below the surface of the liquid and right where rigorous mixing takes place. A ported rotor and stator specially designed to generate powerful vacuum draws powders directly into the high shear zone of the mix chamber. Solids are prevented from floating on the liquid surface. SLIM technology is ideal for the rapid introduction of difficult to wet solids. Wet-out is virtually instantaneous: although the powder, pellets or granules are injected at fast rate, it does not lead to lump formation. SLIM combines the mixing of powders and liquids simultaneously by injecting powders directly into a specially engineered high-shear rotor/stator mixer, where the powder is immediately dispersed into the liquid stream. In most applications, these new solid/liquid injection systems shorten mixing cycles dramatically. The high shear mixers with SLIM from Ross are best for high volume dispersion. Whereas for CMC dispersions, dual-shaft and triple-shaft designs are available ranging from 1-gallon laboratory up to 4,000-gallon production models. For more information, please contact: Ross Process Equipment Pvt Ltd Gat No: 255, Chikhali-Moshi Road Bhoradewadi, Moshi, Pune, Maharashtra 412 105 Tel: 020-65111101, 65111102 E-mail: mail@rossmixers.in

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Electromagnetic Flow Meters Magnetrol introduces the Polaris electromagnetic flow meter, which is capable of measuring liquids with a conductivity as low as 5 ÎźS/cm in closed pipes. It is an accurate and repeatable flow meter that is suitable for a variety of water based and sludge flow applications. The POLARIS transmitter is backlit and rotatable with the capability of measuring forward and reverse flow rates, as well as total volume. HART protocol allows the use of PACTware for configuration and diagnostics. The sensor can be flanged or wafer style and is available with an assortment of standard liners and electrode materials.

Rapid Mixer Granulator Brilliant Pharma mixer is designed to meet special needs of tablet manufacturing technology. This is achieved by reducing processing time, more homogenous mixing uniformity of granule size and above all maintaining improved hygienic standards within the highest GMP norms. Brilliant mixer is designed to achieve all the requirements of GMP current good manufacturing practices. The components are easily dismantable, can be cleaned thoroughly and assembled in quick time. The shaft seals are very effective to check any leakages and cross-contamination due to adherants. The bowl and all the components are of highly polished stainless steel and without sharp corners or devices.

For more information, please contact:

Magnetrol International NV Worldwide Level & Flow Solutions Heikensstraat 6 - 9240 Zele - Belgium Tel: +32 (0)52 45 11 11 , Fax: +32 (0)52 45 09 93 E-mail: kgeerinckx@magnetrol.be

Brilliant Pharma Machinery Unit No: 1, 2 & 14, Modern Indl Estate, Next to Paras Indl Estate, Opp: IPOL, Waliv Phata, Vasai (E), Dist: Thane, Maharashtra 401 208 Tel: 0250-3293636, Fax: 91-0250-2454015 E-mail: brilliantpharma@rediffmail.com

Can Former LANICO offers Can Former from their CF Series. It is a highly efficient and versatile solution for medium and high speed general line can production. It unites a wide working range from 73 to 200 mm dia as well as exceptionally quick changeovers and production speed of up to 300 cans per minute. The machine is suitable for the production of three piece welded necked-in or straight walled general line cans. The CF 411 is applied for producing large milk powder cans, beer kegs, large paint cans and all kinds of large food cans and general line cans. Equipped with three carousels, the Can Former offers utmost reliability and flexibility for different material specifications. A variety of mountable toolsets allows numerous operations to be performed as, eg, necking, flanging, bottom and top end seaming. Further options are beading, die-necking, spinflanging and curling. The welded can bodies are fed vertically to the machine. They are separated by infeed spirals and transported to the first of up to two flanging or necking and flanging carousels. As a next step, the can bodies are transferred to the following carousels by means of synchronised star wheels for beading or seaming bottom and top ends. For more information, please contact: LANICO Maschinenbau Otto Niemsch GmbH Broitzemer Strasse 25-28, 38118 Braunschweig, Germany Tel: +49 53 18 090 614, Fax: +49 53 18 090 627 E-mail: kaufmann@lanico.de

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Zero Hold-up Horizontal Plate Closed Pressure Filter The plate pack assembly consists of plates with interlocking cups, plate rings, perforated screens and filter media. Interlocking cups arranged one above the other, forms single pipeline. The unfiltered liquid is centrally fed under pressure from bottom inlet. The liquid spreads out equally on each plate fitted with filter media. Solids remain on the filter media and clear filtrate flows through gaps on the supporting ring and collects in the shell, which is led out through outlet pipeline. In this process, solids are evenly distributed on each plate. At the end of the cycle the cake can be dried maximum by applying oil or inert gas. It finds application in pharma, fine chemicals, perfumes, resins, etc.

Zero Hold-up Filter Press In this type of filter system, the unfiltered liquid to be filtered enters the filter from the bottom under pressure into the center channel and goes to the top of each plate fitted with filter media and spreads equally. The solid remain on the filter media and crystal clear filtrate flows out from openings on side of plates to the shell, which is led out through outlet pipeline. Filtration is continued until the cake holding capacity of the unit is reached or until rate becomes too slow due to cake resistance. In this system, solids are evenly distributed on each plate which is easily retained in form of cake and it can be dried by applying maximum air or inert gas, steam at the end of cycle. Thus, this type of flow also ensures almost 100 per cent filtration of the liquid and is capable of filtering up to 1 micron size. This type of filter system is extensively used in the field of pharma, fine chemicals, food processing, beverages, distilleries, ink, oils, sugar, syrup, etc.

For more information, please contact:

Subhodh Engg Pvt Ltd Plot No: A-3145, Road No: 34 Wagle Indl Estate, Thane, Maharashtra 400 604 Tel: 022-25810403, 25837791,Telefax: 91-022-25821392 E-mail: subodh314@vsnl.net

Bombay Pharma Equpments Pvt Ltd Gala No: 02, PVK Compound, Laxminarayan Mandir Marg, Kherani Road, Saki Naka, Mumbai 400 072 Tel: 022-28594877,Fax: 91-022-28521608 E-mail: bombaypharma@mtnl.net.in

Smartphone-Connected Wireless Temperature Recorder OCEASOFT launches OCEASOFT Emerald, a wireless temperature recorder connected to your smartphone via Bluetooth SMART. This miniaturised sensor dedicated to the transportation of sensitive and perishable goods has the capability of supervising temperatures in real-time without any specific installation required. The Bluetooth SMART enables Emerald device to read the temperature at regular intervals, stores the data and then informs users in case of any unexpected temperature. All you need is a smartphone to program Emerald and view stored temperature readings. Just scan the code on the back of the module to download the EmeraldView free App easily. Emerald is slightly larger than a wristwatch. During transportation of goods, Emerald tracks temperature regularly and stores up to 4,000 readings in its memory. Data is uploaded to the Cloud along with geolocation information provided by the smartphone to which all authorized users have instant access. Emerald does not require any dedicated equipment, docking station or complex computer installations, just a smartphone. For more information, please contact: LISALINE Lifescience Technologies Pvt Ltd G 19 Flower Valley Commercial Complex. Off Eastern Express Highway, Panchpakhadi, Thane, Maharashtra 400601 Tel: 022-25476796, 25472172, Fax: 91-022-25472426 E-mail: info@lisalineasia.com

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Single Rotary Tablet Press Parle Elizabeth Tools Pvt Ltd offers single rotary tablet press ideally suited for R&D plants, pilot scale production, pharmacy colleges, high value low volume products and non-pharma applications. It is fully cGMP compliant tablet press in terms of design, metallurgy, easy accessibility, etc. It has turret with electroless nickel plating for excellent corrosion resistance and can be provided with D, B or combination D, B and BB tooling. Large capacity motor ensures no jerks/slippages even when compressing large tablets. It has equal sized pre and main compression rollers of 60 kN (6 Ton) capacity each; double paddle force feeder with peek plate with clockwise and counter clockwise rotation of paddles; pull down cam for reduced dust generation during upper punch entry; segmented upper cam for easy cleaning and maintenance; main and feeder motor control through AC variable frequency drive. The integrated control panel includes: touch screen HMI, mode selector switch for setup/off/run, start/stop switches and emergency stop. Compression and ejection force measurement with load cell and NI system (optional). For more information, please contact: Parle Elizabeth Tools Pvt Ltd 102 & 202 Rajvidesh ,Building No: 9, Prime Indl Complex Sativali Road, Waliv, Vasai (E), Thane, Maharashtra 401 208 Tel: 0250-2451867, 6456833, 6456856,Fax: 91-0250-2452842 E-mail: info@parle-elizabeth.com / sales@parle-elizabeth.com

Cartoning Machine The new CUT 1405 from Bosch Packaging Technology is characterized by a flexible choice for the appropriate in-feed systems, formats and closure options. It can safely and gently handle different carton sizes and packages a wide variety of primary packaging such as bottles, vials, syringes, ampoules, tubes, blisters and trays as well as bags, stick packs and sachets in folding cartons. Inserts to single and combination products such as spoons or outserts can also be integrated into the modular in-feed system. With its quickly exchangeable modules for tuck-in, glue and combination closures, the machine can be flexibly used for various products and line combinations. In addition to pharmaceuticals, the new CUT 1405 is also especially suitable for the packaging of cosmetic and food products. The intermittent cartoner can be equipped with diverse in-feed systems, ensuring maximum flexibility for customized line concepts as well as the packaging of different products and product combinations. The CUT 1405 further features an optimized conveyor technology of the folding carton magazine. To prevent the cartons from getting caught, they are transported into the magazine by a lifting motion of the rake. A mechanical gripper arm carries out leaflet in-feed, which is directlyassigned to each product. A shift register checks and follows all products, to ensure that leaflets are only processed further if the outcome of all test results is positive. For more information, please contact: Bosch Packaging Technology Stuttgarter StraĂ&#x;e 130, 71332 Waiblingen Deutschland, Germany Tel: +49 711 811-0, Telefax: +49 711 811-45 000 E-mail: packaging-ph@bosch.com

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events diary 3 rd Annual Global Pharma Regulatory BIOtech Japan - ABLE India Pavilion Dates: 14 -16 May 2014 Summit India 2014 th

Dates: 23 rd-25 th April 2014 Venue: Holiday Inn, Mumbai Pharma is one sector where India is widely accepted to have manufacturing competence. If that credibility is eroded, current plans to boost pharma exports to $20 billion by 2020 will turn into a pipe dream. Thus the Indian pharma must turn proactive and consider a self-regulatory body. Keeping this in issue in mind, CPhI India brings to you the 3rd Annual Global Pharma Regulatory Summit to provide insights on the issues of regulatory compliance. Contact: Tel: +91 (022) 61727001/+91 (022) 61727272 Email: conferences-india@ubm.com

Venue: Tokyo Big Sight, Japan Biotech Japan, an International Biotechnology Exhibition & Conference, is the Asia’s largest trade show for Biotechnology. 2014 Edition is expecting 650 exhibitors, 250 presentations and 15,000 visitors with a wide scope for all players in the field with Interactive networking opportunity involving academics, biotech companies & pharma companies! Contact: Brinda Rajendran Association of Biotechnology Led Enterprises – ABLE Tel: +91-80-4163 6853 / 2563 3853 E-mail:info@ableindia.org

4th Pharmacovigilance, Risk Management BIO International Convention - ABLE & AER India Pavilion Dates: 6th-7th May 2014 Venue: Philadelphia, PA, USA

Dates: 23 rd -26 th June 2014 Venue: San Deigo, California, USA

The 4th Pharmacovigilance, Risk Management & AER Conference will address many pressing concerns regarding drug safety, including effectively identifying and managing potential risks and ensuring a balanced benefit-risk ratio. Top pharmaceutical and biotech representatives will discuss the current complexities and key challenges in pharmacovigilance and risk management throughout the product lifecycle. By attending this conference, delegates will gain a comprehensive understanding of the challenges being faced by professionals working in pharmacovigilance. Hot topics, such as the use of social media in signal detection and the role of pharmacovigilance across the product lifecycle will be discussed as well. In addition, attendees will have the opportunity to engage in meaningful conversations with their peers who are dealing with many such similar issues involving pharmacovigilance, risk management, and adverse event reporting.

The BIO International Convention 2014, San Diego happening this June 23rd - 26th, brings together life science leaders and policy makers from around the globe covering the wide spectrum of life science innovations and application areas. Key elements of the event include education, networking, BIO Business Forum partnering and the 1,700 companies showcasing the latest technologies, products and services in the BIO Exhibition. Contact: Brinda Rajendran Association of Biotechnology Led Enterprises – ABLE Tel: +91-80-4163 6853 / 2563 3853 E-mail:info@ableindia.org

Contact: Tyler Kelch Marketing & PR Coordinator, marcus evans Tel: +1-312-894-6377 E-mail: tylerke@marcusevansch.com 60 March 2014

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bookshelf Vaccine Design: Innovative Approaches and Novel Strategies [Hardcover] Authors: Rino Rappuoli (Editor), Fabio Bagnoli (Editor) Price: USD 313.63 No of Pages: 394 pages About the Book: Vaccines have long been used to combat infectious diseases, however the last decade has witnessed a revolution in the approach to vaccine design and development. No longer is there a need to rely on the laborious classical methods, such as attenuation or killing the pathogen. Now, sophisticated technologies - such as genomics, proteomics, functional genomics, and synthetic chemistry - can be used for the rational identification of antigens, the synthesis of complex glycans, the generation of engineered carrier proteins, and much more. Never has research in this area been more exciting. In this book, expert international contributors critically review the current cutting-edge research in vaccine design and development. Particular emphasis is given to new approaches and technologies.

Novel Anticancer Agents: Strategies for Discovery and Clinical Testing Hardcover Authors: Alex A Adjei (Editor), John K Buolamwini (Editor) Price: USD 189.0 No of Pages: 464 pages About the Book: This book offers pertinent basic science information on strategies used for the rational design and discovery of novel anticancer agents, and, in addition, translational studies involving clinical trial design and execution with these novel, mostly cytostatic agents. This book covers basic science strategies that are being used in drug discovery and preclinical evaluation focused on novel molecular targets, as well as clinical trial methodology including clinical pharmacokinetics and imaging to address issues of efficacy evaluation of the new, relatively non-cytotoxic anticancer agents.

Introduction to Biological and Small Molecule Drug Research and Development: Theory and Case Studies [Hardcover] Authors: C Robin Ganellin (Editor), Roy Jefferis (Editor), Stanley M Roberts (Editor) Price: USD 82.48 No of Pages: 472 pages About the Book: Introduction to Biological and Small Molecule Drug Research and Development provides, for the first time, an introduction to the science behind successful pharmaceutical research and development programs. The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches. The latter part of the book provides carefully selected real-life case studies illustrating how the theory presented in the first part of the book is actually put into practice. Studies include Herceptin/T-DM1, erythropoietin (Epogen/Eprex/NeoRecormon), anti-HIV protease inhibitor Darunavir, and more.

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Renishaw India Spectroscopy Products Division GK Archade, 3rd floor, No.125/1-18 1st Block Jayanagar Bangalore-560011

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inVia - the only Raman system you'll ever need

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The identification of polymers and polymer blends, and the determination of quality.

Research and quality control of protective coatings, such as diamond-like carbon (DLC), and of paints and adhesives.

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R.N.I. No.: MAHENG/2002/08502. Date of Publication: 1â&#x20AC;&#x2122;st of every month. Postal Registration No: MH/MR/SOUTH-284/2014 -16. Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 64